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Brainsway Ltd.

Brainsway Ltd.BWAY決算レポート

Nasdaq · ヘルスケア · 外科用及び医療用器具

BrainsWay Ltd. is an international company that is engaged in the development of a medical device that uses H-coil for deep transcranial magnetic stimulation as a non-invasive treatment for depression, OCD, and smoking addiction. The company was founded in 2003 and has offices in the US and Jerusalem.

What changed in Brainsway Ltd.'s 20-F — 2023 vs 2024

Top changes in Brainsway Ltd.'s 2024 20-F

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Item 4. Mine Safety Disclosures

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Our pivotal trial for MDD demonstrated statistically significant response and remission rates of 38.4% and 32.6%, respectively, in week five of Deep TMS treatment of 20 minutes per session, compared to 21.4% and 14.6%, respectively, after sham treatment.
Our pivotal trial for MDD demonstrated statistically significant response and remission rates of 38.4% and 32.6%, respectively, in week five of Deep TMS treatment of 20 minutes per session, compared to 21.4% and 14.6%, respectively, after sham treatment.
Our pivotal trial for OCD demonstrated statistically significant response and partial response rates of 38.1% and 54.8%, respectively, after six weeks of daily active Deep TMS treatment of 19 minutes per session, compared to 11.1% and 26.7%, respectively, after sham treatment.
Our pivotal trial for OCD demonstrated statistically significant response and partial response rates of 38.1% and 54.8%, respectively, after six weeks of daily active Deep TMS treatment of 19 minutes per session, compared to 11.1% and 26.7%, respectively, after sham treatment.
Positive coverage decisions for Deep TMS for OCD have been issued by Centene Corporation (with 26 million covered lives), Health Care Service Corporation (HCSC) (with 17 million covered lives), TriCare (with 9.6 million covered lives), Cigna Corporation (with 17 million covered lives), Highmark (with 6.8 million covered lives), Premera (with 2.6 million covered lives) and LifeWise (with 2.2 million covered lives).
Positive coverage decisions for Deep TMS for OCD have been issued by Centene Corporation (with 26 million covered lives), Health Care Service Corporation (HCSC) (with 17 million covered lives), TriCare (with 9.6 million covered lives), Cigna Corporation (with 17 million covered lives), Highmark (with 6.8 million covered lives), Premera (with 2.6 million covered lives) and LifeWise (with 2.2 million covered lives).
We focus on the population segment for whom conventional treatment (medicinal and/or psychotherapy) of MDD has not provided the required clinical response, as patients who are treatment-resistant and are entitled to reimbursement for Deep TMS treatment.
We focus on the population segment for whom conventional treatment (medicinal and/or psychotherapy) of MDD has not provided the required clinical response, as patients who are treatment-resistant are entitled to reimbursement for Deep TMS treatment.
Categorizing patients according to “clusters” of clinical depressive and anxiety baseline symptoms derived from a subset of the Hamilton Depression Rating Scale (HDRS-21) resulted in two subject groups: One with higher severity of the cluster, which on average responded better to the H1 Coil, and another with lower severity of the cluster, which on average responded better to the H7 Coil.
Categorizing patients according to “clusters” of clinical depressive and anxiety baseline symptoms derived from a subset of the Hamilton Depression Rating Scale (HDRS-21) resulted in two subject groups: One with higher severity of the cluster, which on average responded better to the H1 Coil, and another with lower severity of the cluster, which on average responded better to the H7 Coil.
This analysis also showed that brain activity measured during the first treatment session correlated with the clinical outcomes ultimately achieved after the full course of treatment. This finding suggests that specific brain patterns observed in an individual’s response to either coil during the early stages of treatment might be predictive of the longer-term outcome of treatment with that coil.
This analysis also showed that brain activity measured during the first treatment session correlated with the clinical outcomes ultimately achieved after the full course of treatment. This finding suggests that specific brain patterns observed in an individual’s response to either coil during the early stages of treatment might be predictive of the longer-term outcome of treatment with that coil.
Additional potential revenues may be derived from extended warranty fees paid for the system for service coverage beyond the standard included warranty period, and from variable or usage fees based on the number of treatments performed with the system.
Additional potential revenues may be derived from extended warranty fees paid for the system for service coverage beyond the standard included warranty period, and from variable or usage fees based on the number of treatments performed with the system.
The review concluded that "[t]he main areas of serotonin research provide no consistent evidence of there being an association between serotonin and depression, and no support for the hypothesis that depression is caused by lowered serotonin activity or concentrations." The review, however, did not refute the body of evidence showing that randomized clinical trials (RCTs) comparing SSRIs to placebo have consistently demonstrated statistical significance in reducing depression.
The review concluded that “[t]he main areas of serotonin research provide no consistent evidence of there being an association between serotonin and depression, and no support for the hypothesis that depression is caused by lowered serotonin activity or concentrations.” The review, however, did not refute the body of evidence showing that randomized clinical trials (RCTs) comparing SSRIs to placebo have consistently demonstrated statistical significance in reducing depression.
We further believe these enhancements hold the potential to make Deep TMS even more attractive for clinicians, researchers, and patients, and may serve to better position its use in neurology. 33 ● Increase our international commercial footprint We are working to expand our existing commercial footprint in Europe, Asia, Latin America, Australia, the broader Middle East, and to pursue commercialization in additional markets.
We further believe these enhancements hold the potential to make Deep TMS even more attractive for clinicians, researchers, and patients, and may serve to better position its use in neurology. ● Increase our international commercial footprint We are working to expand our existing commercial footprint in Europe, Asia, Latin America, Australia, and the broader Middle East, and to pursue commercialization in additional markets.
Considering the rate of comorbidity, we estimate that 12.6 to 18.9 million adults experience moderate to severe anxiety in addition to their primary diagnosis of depression. Common anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly.
Therefore, considering the rate of comorbidity, we estimate that 12.6 to 18.9 million adults experience moderate to severe anxiety in addition to their primary diagnosis of depression. Common anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly.
The training for operation of a Deep TMS system is relatively simple and generally requires a day of training which includes classroom lectures as well as a number of hours of practice providing treatment. The OCD and smoking training protocols, respectively, also include tailored provocation procedures tailored to provoke the specific obsessions, compulsions, or addictions, as relevant, of the subject.
The training for operation of a Deep TMS system is relatively simple and generally requires a day of training which includes classroom lectures as well as a number of hours of practice providing treatment. The OCD and smoking training protocols also include tailored provocation procedures tailored to provoke the specific obsessions, compulsions, or addictions, as relevant, of the subject.
Other adverse reaction reactions such as jaw and face pain, muscle pain, spasm or twitching, and neck pain were reported as mild or moderate and were also resolved shortly after treatment, as well as seizures in certain patients. The less severe side effects associated with Deep TMS make it an attractive option for patients.
Other adverse reactions such as jaw and face pain, muscle pain, spasm or twitching, and neck pain were reported as mild or moderate and were also resolved shortly after treatment, as well as seizures in certain patients. The less severe side effects associated with Deep TMS make it an attractive option for patients.
Baseline demographic, clinical and safety assessments were performed on the ITT analysis set. Primary efficacy analysis was performed only on the PP group. (b) Trial Results The primary efficacy endpoint was a change in the HDRS total score from baseline through week five. The change was measured as the slope of a graph of time point versus HDRS score.
Baseline demographic, clinical and safety assessments were performed on the ITT analysis set. Primary efficacy analysis was performed only on the PP group. 65 (b) Trial Results The primary efficacy endpoint was a change in the HDRS total score from baseline through week five. The change was measured as the slope of a graph of time point versus HDRS score.
According to the World Health Organization (WHO), 1.3 billion people globally use tobacco, primarily cigarette smoking. Globally, more than 8 million people die from smoking each year: 7 million from direct us and 1.2 million from second-hand smoke. Approximately 34 million U.S. adults smoke cigarettes, and 480,000 die from smoking each year.
According to the World Health Organization (WHO), 1.3 billion people globally use tobacco, primarily cigarette smoking. Globally, more than 8 million people die from smoking each year: 7 million from direct use and 1.2 million from second-hand smoke. Approximately 34 million U.S. adults smoke cigarettes, and 480,000 die from smoking each year.
We may also face competition from the SAINT™ Neuromodulation protocol (Magnus Medical), a brain stimulation technique for treatment of neuropsychiatric disorders, which received an FDA clearance for the treatment of MDD in adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode.
We also face competition from the SAINT™ Neuromodulation protocol (Magnus Medical), a brain stimulation technique for treatment of neuropsychiatric disorders, which received an FDA clearance for the treatment of MDD in adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode.
It was conducted at 14 sites, primarily in the U.S., and enrolled 262 eligible subjects randomized into two groups: an active treatment group treated with our proprietary H4 Coil targeting addiction-related brain circuits, and a sham (placebo) control group.
It was conducted at 14 sites, primarily in the U.S., and enrolled 262 eligible subjects randomized into two groups: an active treatment group treated with our proprietary H4 Coil targeting addiction-related brain circuits, and a sham control group.
Furthermore, in August 2022, based on a randomized, double-blind, controlled multicenter, non-inferiority study of our H1 and H7 Coils, the Company's MDD clearance, which had previously applied to its H1 Coil, was extended to also apply to its H7 Coil.
In August 2022, based on a randomized, double-blind, controlled multicenter, non-inferiority study of our H1 and H7 Coils, the Company’s MDD clearance, which had previously applied to its H1 Coil, was extended to also apply to its H7 Coil.
That said, assuming a course of treatment per patient of 18 treatment sessions, and assuming an average price paid to us per treatment session of $50, we believe our total annual addressable market opportunity for smoking addiction in the United States is approximately between $3.9 and $4.1 billion. 28 Our first commercial H1 Coil Deep TMS product received clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant medication in the current episode.
That said, assuming a course of treatment per patient of 18 treatment sessions, and assuming an average price paid to us per treatment session of $50, we believe our total annual addressable market opportunity for smoking addiction in the United States is approximately between $3.9 and $4.1 billion. 52 Our first commercial H1 Coil Deep TMS product received clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant medication in the current episode.
Beyond our existing indications, we are also considering further clinical trials in other neurological and/or addiction areas. Our Strategy We are currently focused on expanding the commercialization of Deep TMS with respect to MDD, OCD and smoking addiction.
Beyond our existing indications, we are also considering further clinical trials in other neurological and/or addiction areas. 59 Our Strategy We are currently focused on expanding the commercialization of Deep TMS with respect to MDD, OCD and smoking addiction.
The data also showed that patients exhibited a significant reduction in disability, with self-reported unproductive days per week dropping from 5.5 days (±0.4) to 1.8 days (±0.4), and self-reported lost days per week dropping from 1.9 (±0.6) to 0.3 days (±0.2). 40 Figure 5.
The data also showed that patients exhibited a significant reduction in disability, with self-reported unproductive days per week dropping from 5.5 days (±0.4) to 1.8 days (±0.4), and self-reported lost days per week dropping from 1.9 (±0.6) to 0.3 days (±0.2). Figure 5.
OCD Durability and Reduction in Unproductivity Deep TMS for Smoking Addiction Disease Overview Smoking is one of the leading causes of death in developed countries. The addiction to nicotine, similar to the addiction to drugs and alcohol, activates the limbic system and causes uncontrollable desire to smoke.
OCD Durability and Reduction in Unproductivity 72 Deep TMS for Smoking Addiction Disease Overview Smoking is one of the leading causes of death in developed countries. The addiction to nicotine, similar to the addiction to drugs and alcohol, activates the limbic system and causes uncontrollable desire to smoke.
Remission rates at week 16 were 31.8% for the Deep TMS group and 22.2% for the sham group, which was a nonsignificant difference between groups (p = 0.1492). 36 Figure 1.
Remission rates at week 16 were 31.8% for the Deep TMS group and 22.2% for the sham group, which was a nonsignificant difference between groups (p = 0.1492). Figure 1.
After the receipt of FDA clearance for our Deep TMS product for smoking addiction, we initiated a clinical data collection effort to facilitate a long term commercial plan for this product. 32 ● Our flexible pricing models are designed to achieve market penetration We market our products utilizing two basic pricing models: (i) a fixed-fee lease model enabling unlimited use; and (ii) a sales or purchase model.
After the receipt of FDA clearance for our Deep TMS product for smoking addiction, we initiated a clinical data collection effort to facilitate a long-term commercial plan for this product. 58 ● Our flexible pricing models are designed to achieve market penetration We market our products utilizing two basic pricing models: (i) a fixed-fee lease model enabling unlimited use; and (ii) a sales or purchase model.
While ECT has high proven efficacy (70-75%) for patients with MDD, ECT’s potential for serious side effects, as well as negative stereotypes surrounding the treatment, often cause patients to be reluctant to undergo ECT. ECT affects the entire brain, including parts which do not need treatment, and may cause permanent cognitive damage, including memory loss.
While ECT has high proven efficacy (70-75%) for patients with MDD, ECT’s potential for serious side effects, as well as negative stereotypes surrounding the treatment, often cause patients to be reluctant to undergo ECT. In addition, ECT affects the entire brain, including parts which do not need treatment, and may cause permanent cognitive damage, including memory loss.
In 2013, the FDA cleared Deep TMS for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode. 35 (a) Trial Design This randomized, double-blind, placebo-controlled, multicenter trial investigated the efficacy and safety of Deep TMS in 212 treatment-resistant adult MDD patients.
In 2013, the FDA cleared Deep TMS for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode. 64 (a) Trial Design This randomized, double-blind, placebo-controlled, multicenter trial investigated the efficacy and safety of Deep TMS in 212 treatment-resistant adult MDD patients.
Competitors that sell other forms of TMS therapy for MDD include Neuronetics, MagVenture, Magstim, Neurocare (MAG & More), Cloud TMS, Nexstim, Yingchi Medical, Sebers, and Magnus Medical that compete directly with us. Their systems are typically based on traditional TMS utilizing a figure-8 coil and are generally FDA-cleared for MDD.
Competitors that sell other forms of TMS therapy for MDD include Neuronetics, MagVenture, Magstim, Neurocare (MAG & More), Cloud TMS, Nexstim, Yingchi Medical, Sebers, Magnus Medical, NeuroQuore, and BTL that compete directly with us. Their systems are typically based on traditional TMS utilizing a figure-8 coil and are generally FDA-cleared for MDD.
When depressive symptoms return more than 12 months after the initial episode of MDD is resolved, it is considered to be a recurrence of the illness and is deemed a new and distinct episode. A response to treatment is commonly measured as a clinically significant decrease in symptoms on a standardized rating scale from baseline scores.
When depressive symptoms return more than twelve months after the initial episode of MDD is resolved, it is considered to be a recurrence of the illness and is deemed a new and distinct episode. A response to treatment is commonly measured as a clinically significant decrease in symptoms on a standardized rating scale from baseline scores.
While the criteria for this emerging Deep TMS for OCD coverage varies with each payor, generally, coverage requires the failure of between two and four medication trials before qualifying for reimbursement. Our strategy is to look for ways to facilitate increased coverage for OCD treatment by more payors, including both commercial and governmental.
While the criteria for Deep TMS for OCD coverage varies with each payor, generally, coverage requires the failure of between two and four medication trials before qualifying for reimbursement. Our strategy is to look for ways to facilitate increased coverage for OCD treatment by more payors, including both commercial and governmental.
Figure 4 highlights the continued decrease in unadjusted mean YBOCS score from baseline over the ten-week period. Figure 4.
Figure 4 highlights the continued decrease in unadjusted mean YBOCS score from baseline over the ten-week period. 71 Figure 4.
Key competitive factors affecting the commercial success Deep TMS System are likely to be efficacy, safety and tolerability, reliability, convenience and time frame of administration, market acceptance of our products relative to alternative treatments, and reimbursement.
Key competitive factors affecting the commercial success of the Deep TMS system are likely to be efficacy, safety and tolerability, reliability, convenience and time frame of administration, market acceptance of our products relative to alternative treatments, and availability and scope of reimbursement.
After the receipt of FDA clearance for our products for smoking addiction, the Company initiated a clinical data collection effort to facilitate and support the long term viability of the commercial plan for this product. ● Pursue additional indications and technological innovations for Deep TMS We are considering expanding the application to other areas as well including - neurological and/or addiction disorders.
After the receipt of FDA clearance for our products for smoking addiction, we initiated a clinical data collection effort to facilitate and support the long-term viability of the commercial plan for this product. ● Pursue additional indications and technological innovations for Deep TMS We are considering expanding the application of Deep TMS to other areas including neurological and/or addiction disorders.
We believe that Deep TMS represents a platform technology with the potential to treat a variety of other psychiatric, neurological and addiction disorders. We are planning clinical trials in other areas, including neurological and/or addiction disorders. Our current customers are principally doctors, hospitals, and medical centers in the field of psychiatry.
We believe that Deep TMS represents a platform technology with the potential to treat a variety of other psychiatric, neurological and addiction disorders. We are actively conducting and/or planning clinical trials in new areas, including neurological and/or addiction disorders. Our current customers are principally doctors, hospitals, and medical centers in the field of psychiatry.
Enrolled subjects were randomized to either treatment with active Deep TMS or a sham. Deep TMS for OCD was used for all treatment sessions, each of which lasted 18.3 minutes. BrainsWay OCD is specifically used in OCD treatment because it targets the anterior cingulate cortex, a region believed to be affected by OCD. The trial consisted of three phases.
Enrolled subjects were randomized to either treatment with active Deep TMS or a sham. Deep TMS for OCD was used for all treatment sessions, each of which lasted 18.3 minutes. Our H7 Coil is specifically used in OCD treatment because it targets the anterior cingulate cortex, a region believed to be affected by OCD. The trial consisted of three phases.
Our capital expenditures for the years ended December 31, 2023, 2022, and 2021 were approximately $2.3 million, $1.7 million and $2.2 million, respectively. Our current capital expenditures primarily involve purchase of equipment and system components in both Israel and the United States.
Our capital expenditures for the years ended December 31, 2024, 2023, and 2022 were approximately $3.8 million, $2.3 million and $1.7 million, respectively. Our current capital expenditures primarily involve purchase of equipment and system components in both Israel and the United States.
According to a 2018 study cited by the World Health Organization (WHO), depression affects approximately 300 million people worldwide, with the rate of depression increasing in developed countries. The U.S. National Institute of Mental Health (NIMH) estimates that 21.0 million individuals in the United States suffer from a major depressive episode in 2020.
According to a 2018 study cited by the World Health Organization (WHO), depression affects approximately 300 million people worldwide, with the rate of depression increasing in developed countries. The U.S. National Institute of Mental Health (NIMH) estimates that 21.0 million adults in the United States suffer from a major depressive episode in 2021.
Figure 2. HDRS Score Change (Slope) and Remission Rates for Deep TMS and Sham Groups in Subpopulations of Patients Who Failed 1 to 2 Medications versus Patients Who Failed 3+ Medications Source: Levkovitz et al., 2015 37 I Safety Results Overall, Deep TMS treatment was safe and well-tolerated by patients.
HDRS Score Change (Slope) and Remission Rates for Deep TMS and Sham Groups in Subpopulations of Patients Who Failed 1 to 2 Medications versus Patients Who Failed 3+ Medications Source: Levkovitz et al., 2015 (c) Safety Results Overall, Deep TMS treatment was safe and well-tolerated by patients.
We completed our initial public offering on the TASE in January 2007, and in April 2019 we completed the listing of our ADSs on The Nasdaq Global Market. Our Ordinary Shares are currently listed on the TASE under the symbol “BWAY”, and our ADSs are currently listed on The Nasdaq Global Market under the symbol “BWAY”.
We completed our initial public offering on the TASE on January 4, 2007, and on April 16, 2019 we completed the listing of the ADSs on The Nasdaq Global Market. Our Ordinary Shares are currently listed on the TASE under the symbol “BWAY”, and the ADSs are currently listed on The Nasdaq Global Market under the symbol “BWAY”.
The economic burden in the United States for major depressive disorder totaled $326 billion per year between 2010 and 2018.
The economic burden in the United States for major depressive disorder totaled $333 billion per year between 2010 and 2018.
Our research and development costs for the years ended December 31, 2023, 2022, and 2021 amounted to $6.7 million, $7.7 million and $6.3 million, respectively. These research and development costs primarily consisted of expenses incurred in connection with the development of our existing and future indication pipeline, and the development of our Deep TMS system.
Our research and development costs for the years ended December 31, 2024, 2023, and 2022 amounted to $7.2 million, $6.7 million and $7.7 million, respectively. These research and development costs primarily consisted of expenses incurred in connection with the development of our existing and future indication pipeline, and the development of our Deep TMS system.
We are also currently selling Deep TMS for MDD in Canada, Europe, Asia, India, Israel, the United Arab Emirates , and certain other countries. We received reimbursement coverage applicable to Deep TMS in Australia in November 2021 and in Israel in June 2022. We are also increasing our commercialization efforts for Deep TMS for OCD.
We are also currently selling Deep TMS for MDD in Canada, Europe, Asia, India, Israel, and certain other countries. We received reimbursement coverage applicable to Deep TMS in Australia in November 2021 and in Israel in June 2022. We are also increasing our commercialization efforts for Deep TMS for OCD.
However, there is no guarantee that we will ultimately be successful in obtaining marketing clearance for the indications prioritized for further study. 43 Competition The industry for the treatment of mental health diseases, disorders, and other conditions is intensely competitive.
However, there is no guarantee that we will ultimately be successful in obtaining marketing clearance for the indications prioritized for further study or any other new indications. Competition The industry for the treatment of mental health diseases, disorders, and other conditions is intensely competitive.
In addition, Deep TMS is administered at stimulation levels that we believe are as safe and tolerable as Traditional TMS. 31 ● We have obtained FDA marketing authorizations of Deep TMS for MDD (including anxious depression), OCD, and smoking addiction We are the only manufacturer of a TMS device to have been cleared by the FDA for three separate mental health disorder indications based on clinically proven efficacy which was demonstrated in pivotal randomized placebo controlled studies conducted on the device: MDD, for which our H1 Coil device was cleared by the FDA in 2013, (and which clearance was expanded in August 2021 to include reduction of comorbid anxiety symptoms, or anxious depression) and for which our H7 Coil received 510(k) clearance from the FDA in August 2022; OCD, for which our device was classified by FDA as a Class II device in a de novo classification in August 2018; and smoking addiction, for which our device was cleared for short term treatment in August 2020.
In addition, Deep TMS is administered at stimulation levels that we believe are as safe and tolerable as Traditional TMS. 57 ● We have obtained FDA marketing authorizations of Deep TMS for MDD (including anxious depression), OCD, and smoking addiction We are the only manufacturer of a TMS device to have been cleared by the FDA for three separate mental health disorder indications based on clinically proven efficacy which was demonstrated in pivotal randomized placebo-controlled studies conducted on the device: MDD, for which our H1 Coil device was cleared by the FDA in 2013, (and which clearance was expanded in August 2021 to include reduction of comorbid anxiety symptoms, or anxious depression, and then again in May 2024 allowing for treatment of MDD patients ages 69-86) and for which our H7 Coil received 510(k) clearance from the FDA in August 2022; OCD, for which our device was classified by FDA as a Class II device in a de novo classification in August 2018; and smoking addiction, for which our device was cleared for short term treatment in August 2020.
Our currently marketed Deep TMS System is, and any future indications we develop and commercialize will be, subject to intense competition. Our Deep TMS system for MDD competes with existing antidepressant drugs, other TMS therapies and to a lesser degree, more invasive treatments such as ECT, VNS, and DBS.
Our currently marketed Deep TMS system is, and any future indications, expansions or new treatment methods we develop and commercialize will be, subject to intense competition. Our Deep TMS system for MDD competes with existing antidepressant drugs, other TMS therapies and to a lesser degree, more invasive treatments such as ECT, VNS, and DBS.
Comorbid anxiety symptoms are common in patients with major depressive disorder. Between sixty and ninety percent of patients with depression have moderate to severe anxiety. In the United States, an estimated 21.0 million adults experienced at least one major depressive episode in 2020.
Comorbid anxiety symptoms are common in patients with major depressive disorder. Between sixty and ninety percent of patients with depression have moderate to severe anxiety. As noted above, in the United States, an estimated 21.0 million adults experienced at least one major depressive episode in 2021.
Specific elements of our strategy include the following: ● Increase the full-scale commercialization of Deep TMS for MDD, OCD and smoking addiction We are continuing to scale up our commercialization of Deep TMS for MDD as we seek to further penetrate the MDD market, including since September 2021 FDA- cleared treatment to anxious depression and the August 2022 cleared H7 Coil for such treatment.
Specific elements of our strategy include the following: ● Increase the full-scale commercialization of Deep TMS for MDD, OCD and smoking addiction We are continuing to scale up our commercialization of Deep TMS for MDD as we seek to further penetrate the MDD market, including based on the FDA-cleared treatment to anxious depression (received in September 2021) and the H7 Coil cleared by the FDA in August 2022 for such treatment.
Based on this trial, the Company's MDD clearance, which had previously applied to its H1 Coil, was extended by the FDA to also apply to its H7 Coil, which until this clearance were used only for treatment of OCD.
Based on this trial, our MDD clearance, which had previously applied to our H1 Coil, was extended by the FDA to also apply to our H7 Coil, which until this clearance was used only for treatment of OCD.
These flexible offerings are designed to facilitate market penetration by addressing the differing clinical needs and risk tolerance among our customer base. As of December 31, 2023, approximately 44% of our global Deep TMS systems installed base for MDD utilized the fixed-fee lease model, and approximately 56% utilized the sales model.
These flexible offerings are designed to facilitate market penetration by addressing the differing clinical needs and risk tolerance among our customer base. As of December 31, 2024, approximately 43% of our global Deep TMS systems installed base for MDD utilized the fixed-fee lease model, and approximately 57% utilized the sales model.
On a consolidated basis, we generated revenue from leasing, one of our two main categories of activity of $8.5 million, $9.2 million and $11.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.
On a consolidated basis, we generated revenue from leasing, one of our two main categories of activity, of $14.5 million, $8.5 million and $9.2 million for the years ended December 31, 2024, 2023 and 2022, respectively.
The United States is our primary and most strategic market, representing approximately 75% of our revenues for each of the years ended December 31, 2023 and 2022, and 88% of our revenues for the year ended December 31, 2021.
The United States is our primary and most strategic market, representing approximately 81% of our revenues for the year ended December 31, 2024 and approximately 75% of our revenues for each of the years ended December 31, 2023 and 2022.
Our revenue from sales, our other category of activity, of $20.4 million, $16.2 million and $16.2 million for the years ended December 31, 2023, 2022 and 2021, respectively. Our revenue from sale related and other services, of $2.9 million, $1.8 million and $1.9 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Our revenue from sales, our other main category of activity, was $22.4 million, $20.4 million and $16.2 million for the years ended December 31, 2024, 2023 and 2022, respectively. Our revenue from sale-related and other services, was $4.1 million, $2.9 million and $1.8 million for the years ended December 31, 2024, 2023 and 2022, respectively.
In this trial, Deep TMS met its safety and efficacy endpoints and based on these results, we filed a de novo application to the FDA for the Deep TMS (using BrainsWay OCD) in this indication.
In this trial, Deep TMS met its safety and efficacy endpoints and based on these results, we filed a de novo application to the FDA for the Deep TMS (using our H7 Coil) in this indication.
In the United States, we sell our Deep TMS system for the treatment of MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression) and OCD and have recently began marketing our products for the treatment of smoking addictions.
In the United States, we sell our Deep TMS system for the treatment of MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression) and OCD and have also been marketing our products for the treatment of smoking addictions since 2023.
Most of our sales outside the United States are made via the purchase model, although we lease some of our Deep TMS systems as well, and in Israel we have several sites who have enlisted under a pay-per-use model.
A significant part of our sales outside the United States are made indirectly with local distributors and agents. Most of our sales outside the United States are made via the purchase model, although we lease some of our Deep TMS systems as well, and in Israel we have several sites who have enlisted under a pay-per-use model.
We believe that Magnus Medical may attempt to launch a TMS system in 2024 with this protocol being their main offering. In addition, we may face competition from ketamine, which is used as an anesthetic to treat a variety of brain disorders.
Magnus Medical launched its SAINT Neuromodulation System in 2024 with this protocol being their main offering. In addition, we may face competition from ketamine, which is used as an anesthetic to treat a variety of brain disorders.
We have exclusive distribution agreements in various territories, including, notably, in Japan, South Korea, Thailand, Taiwan, the Philippines, and the United Arab Emirates, and are seeking new distribution partners for other strategic markets. Under our distribution agreements, the distributor typically receives an exclusive right to commercialize the Deep TMS in the relevant territory.
We have exclusive distribution agreements in various territories, including, notably, in Canada, Japan, South Korea, Thailand, Taiwan, the Philippines, Italy, Spain, Czech Republic, Greece and India, and are seeking new distribution partners for other strategic markets. Under our distribution agreements, the distributor typically receives an exclusive right to commercialize our Deep TMS system in the relevant territory.
As of December 31, 2023, we had 45 U.S. employees, including 43 sales, marketing and service/operations employees, 1 general and administrative employee, and 1 medical affairs employee.
As of December 31, 2024, we had 49 U.S. employees, including 47 sales, marketing and service/operations employees, 1 general and administrative employee, and 1 medical affairs employee.
The clearance for this indication is categorized as an adjunct therapy, which means that it should be administered in conjunction with other first-line therapies and/or medications, as determined in the independent medical judgment of the treating healthcare professional on a case-by-case basis.
The standard Deep TMS treatment protocol for OCD requires 29 treatment sessions over six weeks. The clearance for this indication is categorized as an adjunct therapy, which means that it should be administered in conjunction with other first-line therapies and/or medications, as determined in the independent medical judgment of the treating healthcare professional on a case-by-case basis.
We currently have distribution and agent agreements in various territories, including, notably, Italy, Spain, Czech Republic, Japan, South Korea, Taiwan, Thailand, the Philippines, and the United Arab Emirates. In Israel, we directly distribute to our customers.
We currently have distribution and agent agreements in various territories, including, notably, Canada, Italy, Spain, Czech Republic, Japan, South Korea, Taiwan, Thailand, Greece, and India. In Israel, we directly distribute to our customers.
We believe that our Deep TMS technology has the potential to be safe and effective for the treatment of a wide range of additional psychiatric, neurological, and addiction disorders. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or planned.
We believe that our Deep TMS technology has the potential to be safe and effective for the treatment of a wide range of additional psychiatric, neurological, and addiction disorders.
Moreover, in Australia, in November 2021, for the first time, coverage applicable to Deep TMS for MDD was granted for adults over the age of 18. Coverage in Australia is available for 35 treatment sessions.
Coverage may be provided for up to 40 treatment sessions, which are to be administered in hospitals. Moreover, in Australia, in November 2021, for the first time, coverage applicable to Deep TMS for MDD was granted for adults over the age of 18. Coverage in Australia is available for 35 treatment sessions.
We are the first and only TMS company to be cleared by the U.S. Food and Drug Administration (FDA) for three separate mental health disorder indications based on clinically proven efficacy as demonstrated in pivotal randomized placebo controlled studies.
We are the first and only TMS company to be cleared by the FDA for three separate mental health disorder indications based on clinically proven efficacy as demonstrated in pivotal randomized placebo-controlled studies. Current indications include MDD, OCD, and smoking addiction.
According to the Centers for Disease Control and Prevention (CDC), approximately 28.3 million U.S. adults smoked cigarettes in 2021, with 68% stating they want to quit and 55% actually attempting to quit. Of those attempting to quit, 7.6 million made a serious attempt to quit (i.e., using medication or counseling).
According to the CDC, approximately 28.3 million U.S. adults smoked cigarettes in 2021, with 68% stating they want to quit and 55% actually attempting to quit. Of those attempting to quit, 7.6 million made a serious attempt to quit (i.e., using medication or counseling). Of those smokers attempting to quit either with or without medical assistance, 2.9 million were successful.
Traditional TMS is limited to stimulating relatively narrower and shallower areas of the brain, and the manual positioning of the figure 8 coil in Traditional TMS may cause inaccuracies in the region treated. Studies suggest that the figure 8 coil misses the target in a substantial number of patients.
Traditional TMS is limited to stimulating relatively narrower and shallower areas of the brain, and the manual positioning of the figure 8 coil in Traditional TMS may cause inaccuracies in the region treated.
For the year ended December 31, 2023, we generated revenues in the United States of $23.9 million, an increase of 18% as compared to $20.3 million for the year ended December 31, 2022.
For the year ended December 31, 2024, we generated revenues in the United States of $33.2 million, an increase of 38.9% as compared to $23.9 million for the year ended December 31, 2023.
Currently, TMS for MDD is generally recommended for treatment-resistant MDD patients. Until recently payors typically required that patients fail multiple antidepressant medications prior to receiving TMS; however, there has been a trend which continued over the past year to reduce the number of required failures to one or two medication failures before qualifying for TMS.
Until recently payors typically required that patients fail multiple antidepressant medications prior to receiving TMS; however, there has been a trend which continued in recent years to reduce the number of required failures to one or two medication failures before qualifying for TMS.
Each system can accommodate two helmets, and a third helmet can be incorporated using a separate auxiliary stand. ● Helmet, including proprietary H- Coil ● Stimulator, which provides the power supply and source of the Deep TMS electromagnetic field ● Graphic User Interface (GUI) ● One or More Arm(s)/Positioning Device(s) ● Cooling System ● Movable Medical Cart 30 We believe our Deep TMS platform has many advantages relative to other TMS systems.
The key components of our Deep TMS system are: ● Helmet, including proprietary H-Coil ● Stimulator, which provides the power supply and source of the Deep TMS electromagnetic field ● Graphic User Interface (GUI) ● One or More Arm(s)/Positioning Device(s) ● Cooling System ● Movable Medical Cart We believe our Deep TMS platform has many advantages relative to other TMS systems.
Deep TMS presents a novel, FDA-authorized treatment for OCD. In August 2018, the FDA classified and provided marketing authorization for Deep TMS for OCD as an adjunct treatment (i.e., to be used in conjunction with first-line treatment, such as antidepressant medication or CBT) for adult patients suffering from OCD.
In August 2018, the FDA classified and provided marketing authorization for Deep TMS for OCD as an adjunct treatment (i.e., to be used in conjunction with first-line treatment, such as antidepressant medication or CBT) for adult patients suffering from OCD. Deep TMS has the unique ability to simultaneously influence a network of specific regions in the brain related to OCD.
When a patient shows no or nearly no symptoms, the patient is referred to as being in remission. Experiencing one episode of MDD places an individual at an estimated 50% risk of experiencing an additional episode of MDD. Approximately 80% of those individuals who have experienced two episodes of MDD will experience an additional episode.
When a patient shows no or nearly no symptoms, the patient is referred to as being in remission. Experiencing one episode of MDD places an individual at an estimated 50% risk of experiencing an additional episode of MDD.
In people with MDD, the complex system of neuronal communication does not function properly. One of the most important discoveries in neuroscience has been the recognition that improper regulation of one or more of the three major neurotransmitters, serotonin, norepinephrine, and dopamine, plays a key role in a patient’s depression.
One of the most important discoveries in neuroscience has been the recognition that improper regulation of one or more of the three major neurotransmitters, serotonin, norepinephrine, and dopamine, plays a key role in a patient’s depression.
Data collected using this approach to treat depression was compiled from clinical sites and analyzed in this study. Key findings from this post-marketing study included data demonstrating efficacy of Deep TMS administered over multiple sessions each day to allow for quicker overall treatment time for depression patients.
Key findings from this post-marketing study included data demonstrating efficacy of Deep TMS administered over multiple sessions each day to allow for quicker overall treatment time for depression patients.
MDD is a common and debilitating mental disorder characterized by physiological symptoms, such as sleep disturbance and changes in appetite, emotional symptoms, such as sadness, despair, emptiness, self-hate, and critique, and cognitive symptoms, such as difficulty concentrating, memory dysfunction, suicidal thinking, and faulty judgment of reality.
Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or planned. 51 MDD is a common and debilitating mental disorder characterized by physiological symptoms, such as sleep disturbance and changes in appetite, emotional symptoms, such as sadness, despair, emptiness, self-hate, and critique, and cognitive symptoms, such as difficulty concentrating, memory dysfunction, suicidal thinking, and faulty judgment of reality.
Research also shows that a type of CBT called Exposure and Response Prevention (EX/RP) is effective in reducing compulsive behaviors in OCD, even in people who did not respond well to antidepressant medication. For many patients EX/RP is the add-on treatment of choice when antidepressant medication does not effectively treat OCD symptoms.
Research also shows that a type of CBT called Exposure and Response Prevention (EX/RP) is effective in reducing compulsive behaviors in OCD, even in people who did not respond well to antidepressant medication.
Following the screening phase, patients entered into a six-week treatment phase. During the first five weeks of the treatment phase, patients received five consecutive sessions per week, followed by one week with four sessions (29 total treatment sessions). The third phase was the follow-up, in which patients were assessed in week six after their final treatment.
Following the screening phase, patients entered into a six-week treatment phase. During the first five weeks of the treatment phase, patients received five consecutive sessions per week, followed by one week with four sessions (29 total treatment sessions).
Patients reporting abstinence at 6 weeks were invited for a long follow-up (L-UP) visit at 4 months. 41 Of the 169 participants in the study who actually completed three weeks of Deep TMS or sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.0% in the treatment group compared to 11.7% in the sham group (p=0.007).
Of the 169 participants in the study who actually completed three weeks of Deep TMS or sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.0% in the treatment group compared to 11.7% in the sham group (p=0.007).
In addition, we could face competition by the recently approved AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults, which are the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD.
In addition, we could face competition by the recently approved AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of MDD in adults, which are the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD. We are also subject to competition from invasive neuromodulation therapies such as ECT, VNS, and DBS.
For the group of patients who failed three or more medications, remission rates were 28.9% for the Deep TMS group and 12.2% for the sham group. This difference was just outside of significance (p = 0.057). The data suggest that Deep TMS treatment can achieve high rates of remission even in patients who have been more resistant to medications.
For the group of patients who failed three or more medications, remission rates were 28.9% for the Deep TMS group and 12.2% for the sham group. This difference was just outside of significance (p = 0.057).
Of those smokers attempting to quit either with or without medical assistance, 2.9 million were successful. Reimbursement is not currently available for Deep TMS for smoking addiction, and it is therefore premature to assess the amount of money our customers might be able to collect from potential payors, and willing to pay us, for treatment for this indication.
Reimbursement is not currently available for Deep TMS for smoking addiction, and it is therefore premature to assess the amount of money our customers might be able to collect from potential payors, and willing to pay us, for treatment for this indication.
Deep TMS therapy for smoking cessation has not demonstrated any systemic side effects, and we believe that Deep TMS presents an attractive alternative to existing treatment options for smoking cessation because antidepressant medications, due to their side effects, often lead to cessation of treatment by the patient and as a result, relapse to smoking.
Deep TMS therapy for smoking cessation has not demonstrated any systemic side effects, and we believe that Deep TMS presents an attractive alternative to existing treatment options for smoking cessation because antidepressant medications, due to their side effects, often lead to cessation of treatment by the patient and as a result, relapse to smoking. 73 We concluded with positive results a pivotal multicenter trial assessing the safety and efficacy of Deep TMS as an aid in smoking cessation in adults suffering from chronic smoking addiction.
We anticipate our capital expenditures and research and development costs in 2024 to be financed from our existing cash and cash equivalents, including the proceeds from the follow-on underwritten public offering of ADSs closed on February 25, 2021, and from our ongoing sales and leases of our Deep TMS systems.
We anticipate our capital expenditures and research and development costs in 2025 to be financed from our existing cash and cash equivalents, including the proceeds from the private placement of ADSs and warrants that closed on November 5, 2024, and from our ongoing sales and leases of our Deep TMS systems.
Real world data further demonstrates the benefits of Deep TMS for MDD: In a peer-reviewed post-marketing study published in Psychiatry Research in 2023, we demonstrated that patients who had received 30 or more Deep TMS treatments achieved an 82% response rate and a 65% remission rate.
These studies suggest that Deep TMS may continue to be effective beyond the standard acute treatment course, potentially broadening its clinical applicability. 67 Real world data further demonstrates the benefits of Deep TMS for MDD: In a peer-reviewed post-marketing study published in Psychiatry Research in 2023, we demonstrated that patients who had received 30 or more Deep TMS treatments achieved an 82% response rate and a 65% remission rate.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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In addition, our second Deep TMS commercial product received FDA marketing authorization in August 2018 as an adjunct therapy for adult patients suffering from OCD, and in August 2018 as an adjunct therapy for adult patients suffering from OCD, and we currently market this product to the same general clientele as our MDD systems.
In addition, our second Deep TMS commercial product received FDA marketing authorization in August 2018 as an adjunct therapy for adult patients suffering from OCD, and we currently market this product to the same general clientele as our MDD systems.
We are also able to leverage our platform technology, which includes the ability to treat multiple indications using different H-Coil helmets, to facilitate transactions utilizing combined pricing models often involving a single system with one or more add-on helmets.
We are also able to leverage our platform technology, which includes the ability to treat multiple indications using different H-Coil helmets, to facilitate transactions utilizing combined pricing models often involving a single system with one or more add-on helmets.
General and administrative costs include, but are not limited to, accounting, legal, human resources, consulting, investor relations, listing fees on The Nasdaq Global Market, costs associated with reporting and compliance in the United States, as well as director and officer insurance premiums, as a result of becoming a public company in the United States.
General and administrative costs also include, but are not limited to, accounting, legal, human resources, consulting, investor relations, listing fees on The Nasdaq Global Market, costs associated with reporting and compliance in the United States, as well as director and officer insurance premiums, as a result of becoming a public company in the United States.
We offer the following main pricing models: ● Sale Model: The Deep TMS system is sold to the customer for a fixed purchase price. 52 ● Fixed-fee Lease Model: The customer leases the Deep TMS system and pays a fixed annual or monthly fee for the term of the lease (generally between 48 and 60 months).
We offer the following main pricing models: ● Sale Model: The Deep TMS system is sold to the customer for a fixed purchase price. ● Fixed-fee Lease Model: The customer leases the Deep TMS system and pays a fixed annual or monthly fee for the term of the lease (generally between 48 and 60 months).
These estimates and judgments are subject to an inherent degree of uncertainty, and actual results may differ. Our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this report.
These estimates and judgments are subject to an inherent degree of uncertainty, and actual results may differ. Our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this Annual Report.
We expect to continue to own those of our Deep TMS systems which have been placed under these models for the foreseeable future, which allows us to maintain our relatively low cost of revenues for those systems.
We expect to continue to own our Deep TMS systems that have been placed under these models for the foreseeable future, which allows us to maintain our relatively low cost of revenues for those systems.
For more information regarding governmental economic, fiscal, monetary or political policies or factors that have materially affected, or could materially affect, directly or indirectly, the Company’s operations in Israel, please see also
For more information regarding governmental economic, fiscal, monetary or political policies or factors that have materially affected, or could materially affect, directly or indirectly, the Company’s operations in Israel, please see also “
Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or planned. 51 Our first commercial H1 Coil Deep TMS product received clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant medication in the current episode.
Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or planned. 92 Our first commercial H1 Coil Deep TMS product received clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant medication in the current episode.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.
OPERATING AND FINANCIAL REVIEW AND PROSPECTS You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.
Selling and marketing expenses Selling and marketing expenses consist of marketing and commercial activities related to the sale and lease of our Deep TMS systems, as well as personnel expenses, including salaries and related benefits, sales commissions, share-based compensation for employees, and facility costs.
Selling and marketing expenses Selling and marketing expenses consist of marketing and commercial activities related to the sale and lease of our Deep TMS systems, as well as personnel expenses, including salaries and related benefits, sales commissions and share-based compensation for employees, collection fees and facility costs.
We expect to continue to incur research and development expenses for the near future as we advance the development of our Deep TMS technology for various neurological and/or addiction disorders, as well as for various hardware and software development projects related to the Deep TMS system.
We expect to continue to incur research and development expenses for the foreseeable future as we advance the development of our Deep TMS technology for various neurological and/or addiction disorders, as well as for various hardware and software development projects related to the Deep TMS system.
In addition, as of December 31, 2023, we had shipped 607 H7 Coils as additional coils attached to certain of our new and existing systems following our receipt in August 2018 of marketing approval from the FDA for our OCD system.
In addition, as of December 31, 2024, we had shipped 743 H7 Coils as additional coils attached to certain of our new and existing systems following our receipt in August 2018 of marketing approval from the FDA for our OCD system.
We are boldly advancing neuroscience with our proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. We are dedicated to leading through superior science and building on what we believe to be an unparalleled body of clinical evidence. We are the first and only TMS company to be cleared by the U.S.
We are boldly advancing neuroscience with our proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. We are dedicated to leading through superior science and building on what we believe to be an unparalleled body of clinical evidence.
Year ended December 31, 2022 compared to year ended December 31, 2021 For comparison of fiscal year 2022 to fiscal year 2021 please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Year ended December 31, 2022 compared to year ended December 31, 2021” section in our annual report on form 20-F filed with the SEC on March 27, 2023.
Year ended December 31, 2023 compared to year ended December 31, 2022 For comparison of fiscal year 2023 to fiscal year 2022 please see “ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Year ended December 31, 2023 compared to year ended December 31, 2022 ” section in our annual report on form 20-F for the year ended December 31, 2023 filed with the SEC on March 28, 2024.
Food and Drug Administration (FDA) for three separate mental health condition indications based on clinically proven efficacy as demonstrated in pivotal randomized placebo controlled studies. Current indications include major depressive disorder (MDD), including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction.
We are the first and only TMS company to be cleared by the FDA for three separate mental health condition indications based on clinically proven efficacy as demonstrated in pivotal randomized placebo-controlled studies. Current indications include major depressive disorder (MDD), including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction.
Research and development expenses, net Research and development expenses, net, consist primarily of personnel expenses, including salaries and related benefits, share-based compensation for employees, facility costs, laboratory materials, regulatory costs, patents, and travel expenses, as well as expenses associated with outsourced professional scientific development services, and the costs of multi-center and other clinical trials.
We expect our cost of revenues to increase in absolute dollars to the extent our revenues increase. 94 Research and development expenses, net Research and development expenses, net, consist primarily of personnel expenses, including salaries and related benefits and share-based compensation for employees, laboratory materials, regulatory costs, patents, facility costs,תand travel expenses, as well as expenses associated with outsourced professional scientific development services, and the costs of multi-center and other clinical trials.
The cost of revenues for systems that we sell primarily consists of the costs of raw materials, including components purchased from our third-party contract manufacturers and manufacturing and assembly of the components that we perform ourselves.
The cost of revenues for systems that we sell primarily consists of the costs of raw materials, including components purchased from our third-party contract manufacturers, and manufacturing and assembly of the components that we perform ourselves. The entire cost of the Deep TMS system is recognized upon such sales.
The cost of revenues for systems that we lease or sell also include costs related to personnel, royalties to PHS and Yeda, shipping, and our operations department. We expect our cost of revenues to increase in absolute dollars to the extent our revenues increase.
The cost of revenues for systems that we lease or sell also includes costs related to personnel, royalties to PHS and Yeda, shipping, and our operations department.
As of December 31, 2023, we had an installed base of approximately 1,101 Deep TMS systems, whereby 514 systems were leased from us, and an additional 587 systems were sold by us prior to December 31, 2023. Our installed base increased by 217 systems during 2023.
As of December 31, 2024, we had an installed base of approximately 1,353 Deep TMS systems, whereby 578 systems were leased from us, and an additional 775 systems were sold by us prior to December 31, 2024. Our installed base increased by 252 systems during 2024.
Finance expenses, net Our finance expenses, net, consist primarily of expenses related to bank charges, and the amortization of deferred financing costs related to our finance expense with respect to the fair value re-measurement related to our outstanding liability to the IIA on account of grants received for financing our research and development activity, as well as interest income earned on our bank deposits and foreign currency exchange transactions.
Finance expenses Our finance expenses consist primarily of financing costs related to our outstanding liability to the IIA on account of grants received for financing our research and development activity, as well as expenses related to bank charges and foreign currency exchange transactions.
Critical Accounting Policies and Estimates The preparation of financial statements, in conformity with IFRS, requires companies to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities at and as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
During the year ended December 31, 2024, we recorded deferred tax assets in respect of temporary differences in the U.S. subsidiary. 95 Critical Accounting Policies and Estimates The preparation of financial statements, in conformity with IFRS, requires companies to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities at and as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
Allowance for doubtful accounts based on expected credit losses on trade receivables We apply a simplified approach and measure the loss allowance in respect of our short -term financial assets, trade receivables, in an amount equal to the lifetime expected credit losses. The Company records an allowance for doubtful accounts based on expected credit losses for trade receivables.
Our estimates are primarily guided by observing the following critical accounting policies: Allowance f or Doubtful Accounts based on Expected Credit Losses on Trade Receivables We apply a simplified approach and measure the loss allowance in respect of our short-term financial assets, trade receivables, in an amount equal to the lifetime expected credit losses.
Year ended December 31, 2023 compared to year ended December 31, 2022 Revenues Our total revenues increased by $4.6 million, or 17%, from $27.2 million for the year ended December 31, 2022 to $31.8 million for the year ended December 31, 2023.
Year ended December 31, 2024 compared to year ended December 31, 2023 Revenues Our total revenues increased by $9.2 million, or 29%, from $31.8 million for the year ended December 31, 2023 to $41.0 million for the year ended December 31, 2024.
General and administrative expenses also include the cost of insurance, professional services, including legal and accounting fees as well as administrative costs, including corporate facility costs. We anticipate that our general and administrative expenses will decrease as we realign our corporate activities.
General and administrative expenses also include the cost of insurance, allowance for doubtful accounts, professional services, including legal and accounting fees, as well as administrative costs, including corporate facility costs.
Three months ended March 31 June 30 Sep. 30 Dec. 31 March 31 June 30 Sep. 30 Dec. 31 March 31 June 30 Sep. 30 Dec. 31 2023 2022 2021 Statements of operations U.S dollars in thousands Revenues 6,625 7,829 8,302 9,029 7,970 8,006 5,168 6,033 6,121 7,005 8,061 8,470 Cost of revenues 1,792 2,095 2,131 2,290 1,867 2,192 1,341 1,729 1,463 1,300 1,930 1,906 Gross profit 4,833 5,734 6,171 6,739 6,103 5,814 3,827 4,304 4,658 5,705 6,131 6,564 Research and development expenses, net 1,785 1,902 1,544 1,434 1,576 1,731 2,220 2,151 925 1,650 1,786 2,032 Selling and marketing expenses 4,912 3,983 3,602 3,959 4,146 4,552 4,751 4,750 3,129 4,191 4,042 4,518 General and administrative expenses 1,803 1,192 1,158 1,162 1,863 1,539 1,726 1,726 1,405 1,377 1,536 1,466 Total Operating expenses 8,500 7,077 6,304 6,555 7,585 7,822 8,697 8,627 5,459 7,218 7,364 8,016 Total operating income (loss) ( 3,667 ) ( 1,343 ) ( 133 ) 184 (1,482 ) (2,008 ) (4,870 ) (4,323 ) ( 801 ) ( 1,513 ) ( 1,233 ) ( 1,452 ) Finance expenses (income), net ( 1,407 ) 135 (38 ) 221 324 329 99 (401 ) 412 269 360 379 Loss before income taxes (2,260 ) (1,478 ) (171 ) (37 ) (1,806 ) ( 2,337 ) (4,969 ) (3,922 ) ( 1,213 ) (1,782 ) (1,593 ) ( 1,831 ) Income taxes (tax benefit) 171 185 59 (164 ) 187 113 70 (55 ) 160 156 211 (484 ) Net income (loss) and Comprehensive income (loss) (2,431 ) (1,663 ) (230 ) 127 (1,993 ) ( 2,450 ) (5,039 ) (3,867 ) (1,373 ) (1,938 ) (1,804 ) (1,347 ) Our quarterly revenues and operating results have varied in the past and are expected to vary in the future due to numerous factors.
Three months ended March 31 June 30 Sep. 30 Dec. 31 March 31 June 30 Sep. 30 Dec. 31 March 31 June 30 Sep. 30 Dec. 31 2024 2023 2022 Statement of Operations (in U.S dollars thousands) Revenues 9,095 10,005 10,502 11,414 6,625 7,829 8,302 9,029 7,970 8,006 5,168 6,033 Cost of revenues 2,283 2,468 2,781 2,903 1,792 2,095 2,131 2,290 1,867 2,192 1,341 1,729 Gross profit 6,812 7,537 7,721 8,511 4,833 5,734 6,171 6,739 6,103 5,814 3,827 4,304 Research and development expenses, net 1,626 1,711 1,809 2,044 1,785 1,902 1,544 1,434 1,576 1,731 2,220 2,151 Selling and marketing expenses 3,827 3,796 4,108 4,472 4,912 3,983 3,602 3,959 4,146 4,552 4,751 4,750 General and administrative expenses 1,266 1,444 1,523 1,564 1,803 1,192 1,158 1,162 1,863 1,539 1,726 1,726 Total Operating expenses 6,719 6,951 7,440 8,080 8,500 7,077 6,304 6,555 7,585 7,822 8,697 8,627 Total operating income (loss) 93 586 281 431 (3,667 ) (1,343 ) (133 ) 184 (1,482 ) (2,008 ) (4,870 ) (4,323 ) Finance income (expenses), net 190 117 456 1,305 1,407 (135 ) (38 ) (221 ) (324 ) (329 ) (99 ) 401 Income (loss) before income taxes 283 703 737 1,736 (2,260 ) (1,478 ) (171 ) (37 ) (1,806 ) (2,337 ) (4,969 ) (3,922 ) Income taxes (tax benefit) 172 103 75 188 171 185 59 (164 ) 187 113 70 (55 ) Net income (loss) and Comprehensive income (loss) 111 600 662 1,548 (2,431 ) (1,663 ) (230 ) 127 (1,993 ) (2,450 ) (5,039 ) (3,867 ) Our quarterly revenues and operating results have varied in the past and are expected to vary in the future due to numerous factors.
For the year ended December 31, 2023, our revenues were $31.8 million compared to $27.2 million for the year ended December 31, 2022, representing an increase of 17% over the revenues generated in 2022. We incurred net losses of $4.2 million for the year ended December 31, 2023.
For the year ended December 31, 2024, our revenues were $41.0 million compared to $31.8 million for the year ended December 31, 2023, representing an increase of 29% over the revenues generated in 2023.
We believe that Deep TMS represents a platform technology that provides for an opportunity to develop additional Deep TMS products for a variety of psychiatric, neurological, and addiction disorders. We are planning clinical trials for other indications, including neurological and/or addiction disorders. Our current customers are principally doctors, hospitals, and medical centers in the field of psychiatry.
We are planning clinical trials for other indications, including neurological and/or addiction disorders. Our current customers are principally doctors, hospitals, and medical centers in the field of psychiatry.
Cost of revenues and gross margin Our cost of revenues includes a significant component of depreciation of the Deep TMS systems, due to the fact that we maintain ownership of those systems placed under various models including our fixed-fee lease model, where we place our system at a site for use by our customer, rather than selling it outright.
In the case of our other models, including our fixed-fee lease model, where we maintain ownership of the Deep TMS systems and place our systems at sites for use by our customers, rather than selling them outright. Cost of revenue for these models includes a significant component of depreciation of the Deep TMS systems.
Income taxes expense Our income taxes expense is derived primarily from income generated from the sales and lease of our Deep TMS systems from our U.S. subsidiary. During the year ended December 31, 2023, the Company recorded deferred tax assets in respect of temporary differences in the U.S. subsidiary.
Income Taxes Expense Our income taxes expense is derived primarily from income generated from the sales and lease of our Deep TMS systems from our U.S. subsidiary.
We have prepared this quarterly information on a basis consistent with our audited financial statements.
A. Operating Results Quarterly Results of Operations The following tables show our unaudited quarterly statements of operations for the periods indicated. We have prepared this quarterly information on a basis consistent with our audited financial statements.
The decrease of $1 million, or 13%, was primarily attributable to a decrease in headcount and in investments in clinical trial and post-marketing studies. 55 Selling and marketing expenses Our selling and marketing expenses were $16.5 million for the year ended December 31, 2023 compared to $18.2 million for the year ended December 31, 2022.
Research and development expenses, net Our research and development expenses, net, were $7.2 million for the year ended December 31, 2024 compared to $6.7 million for the year ended December 31, 2023. The increase of $0.5 million, or 7%, is primarily attributed to an increase in headcount and in investments in clinical trial and post-marketing studies.
Our revenues from sales are recognized when control of the system is transferred to the customer, generally upon delivery of the system.
Our revenues from sales are recognized when control of the system is transferred to the customer, generally upon delivery of the system. Cost of revenues and gross margin Our cost of revenues includes a significant component for the Deep TMS systems that we sell under our sales model.
Cost of revenues and gross margin Our cost of revenues was $8.3 million for the year ended December 31, 2023 compared to $7.1 million for the year ended December 31, 2022. The increase is primarily attributed to increase in sales volumes.
Revenues from sales and leases were 55% and 35%, respectively, of the revenues for the year ended December 31, 2024, compared to 64% and 27%, respectively, of the revenues for the year ended December 31, 2023. 97 Cost of revenues and gross margin Our cost of revenues was $10.4 million for the year ended December 31, 2024 compared to $8.3 million for the year ended December 31, 2023.
The allowance rates are based on days past due for its various customers. The allowance is initially based on the Company’s historical observed default rates as well as forward- looking information. At each reporting date, the historical observed default rates are updated and changes in the forward-looking estimates are analyzed.
We record an allowance for doubtful accounts based on expected credit losses for trade receivables. The allowance rates are based on days past due for our various customers. The allowance is initially based on our historical observed default rates as well as forward-looking information.
The Company also improved its cost effectiveness for marketing expenses by targeting the investments to specific groups and growing markets. General and administrative expenses Our general and administrative expenses were $5.3 million for the year ended December 31, 2023 compared to $6.9 million for the year ended December 31, 2022.
General and administrative expenses Our general and administrative expenses were $5.8 million for the year ended December 31, 2024 compared to $5.3 million for the year ended December 31, 2023.
There has been no material change in our gross margin as a percentage of revenue for the last three years. Research and development expenses, net Our research and development expenses, net, were $6.7 million for the year ended December 31, 2023 compared to $7.7 million for the year ended December 31, 2022.
The increase of $2.1 million, or 26% is primarily attributed to an increase in sales volumes. There has been no material change in our gross margin as a percentage of revenue for the last three years.
The increase in revenues was attributed mainly to an increase in sales of our Deep TMS systems to customers. Revenues from sales were 64% of the revenues for the year ended December 31, 2023, compared to 60% of the revenues for the year ended December 31, 2022.
The increase in revenues is primarily attributed to an increase in leases and sales of our Deep TMS systems to customers.
On February 25, 2021, we closed a follow-on underwritten public offering of ADSs with gross proceeds of approximately $45.2 million before deducting underwriting discount and commissions and offering expenses. We believe that our existing cash resources will be sufficient to enable us to fund our operating expenses and capital expenditure requirements for at least the next 24 months.
On November 5, 2024 we consummated a private placement of 2,103,745 ADSs and warrants to purchase 1,500,000 ADSs to Valor, for aggregate immediate gross proceeds of approximately $20 million. We believe that our existing cash resources will be sufficient to enable us to fund our operating expenses and capital expenditure requirements in the foreseeable future.
We anticipate relative stability in current headcount levels for our commercial organization, and we plan to focus on aligning our current resources with existing territories in order to maximize and enhance efficiency. As a result, we expect our sales and marketing expenses to decrease.
While we anticipate relative stability in current headcount levels for our existing commercial organization, we plan on investing additional resources including certain added roles to align with our strategic and growth initiatives.
In August 2022, we received 510(k) clearance from the FDA for the use of our H7 Coil to treat MDD (including anxious depression). Our sales and marketing efforts are currently focused in the United States, where we generated approximately 75% of our revenues in the year ended December 31, 2023.
In August 2022, we received 510(k) clearance from the FDA for the use of our H7 Coil to treat MDD (including anxious depression). In 2024, we received FDA clearance for an expansion of our existing MDD clearance allowing for the treatment of patients within the 69-86 age range suffering from late life depression.
Recent Accounting Pronouncements The recent accounting pronouncements are set forth in Note 2 to our audited consolidated financial statements beginning on page F-1 of this Annual Report. A. Operating Results Quarterly Results of Operations The following tables show our unaudited quarterly statements of operations for the periods indicated.
Changes in estimated future cash flows and estimated discount rates, after consideration of risks such as liquidity risk, credit risk and volatility, are liable to affect the fair value of these assets of liability. 96 Recent Accounting Pronouncements The recent accounting pronouncements are set forth in Note 2 to our audited consolidated financial statements beginning on page F-1 of this Annual Report.
The increase of $1.4 million is mainly attributed to an increase in interest income from bank deposits. For information on the impact of currency fluctuations on the company, please see Item 11 “Quantitative and Qualitative Disclosures About Market Risk” below.
Finance expenses, net Our finance income, net, was $2.0 million for the year ended December 31, 2024 compared to finance income, net of $1.0 million for the year ended December 31, 2023. The increase of $1.0 million is primarily attributed to remeasurement of warrants. For information on the impact of currency fluctuations on the company, please see “ Item 11.
As of December 31, 2023, we had an accumulated deficit of $101.3 million.
Our net income for the year ended December 31, 2024 was $2.9 million, compared to net loss of $4.2 million for the year ended December 31, 2023. 93 As of December 31, 2024, we had an accumulated deficit of $98.4 million.
The decrease of $1.6 million, or 23% is mainly attributed to lower Directors and Officers' insurance fees as well as restructuring and decrease in allowance for doubtful debts. Finance expenses, net Our finance income, net, was $1 million for the year ended December 31, 2023 compared to finance expenses, net of $0.4 million for the year ended December 31, 2022.
Selling and marketing expenses Our selling and marketing expenses were $16.2 million for the year ended December 31, 2024 compared to $16.5 million for the year ended December 31, 2023. The decrease of $0.3 million, or 2%, is primarily attributed to a decrease in the costs of the commercial team in the United States.
Removed
In the case of the Deep TMS systems that we sell under our sales model, the entire cost of the Deep TMS system is recognized upon such sale.
Added
Item 5. Operating and Financial Review and Prospects—C. Research and Development, Patents and Licenses .” Government Grants As of December 31, 2024, we have received grants from the IIA in an aggregate amount of approximately $13.4 million.
Removed
While continuing to pursue these strategic initiatives, we also plan on streamlining existing resources as we shift more of our focus to our commercial operations. As a result, we expect our research and development expenses to decrease.
Added
We are currently required to pay 3% royalties of sales of our Deep TMS products, which payment obligations do not currently exceed the amount of the grant received (in U.S. dollars), plus interest at an annual rate equal to the LIBOR rate.
Removed
Our estimates are primarily guided by observing the following critical accounting policies: 53 Revenue Recognition We generate revenues from the sale and lease of our systems.
Added
As of December 31, 2024, we have paid royalties to the IIA in an aggregate amount of approximately $6.2 million (including amounts in respect of accrued interest), with remaining outstanding royalties of up to $10.1 million. 79 In addition, we received from MAGNET approvals for grants in an aggregate amount of NIS 8.2 million (approximately $2.2 million based on the NIS to USD exchange rate as of December 31, 2024).
Removed
We sell products mainly directly to end users, third party financing companies with arrangements with end users, and to a lesser extent, to third-party distributors outside of the United States which typically do not include return rights.
Added
There is no requirement to repay the grants or pay royalties thereon. Manufacturing and Supply We manage all aspects of product supply through our Jerusalem and/or U.S.-based operations teams.
Removed
We typically have post-sale obligations of training and installation of our systems and may provide an annual service warranty for the Deep TMS system after the expiration of the standard warranty. Revenues for such services are deemed distinct performance obligations and are recognized when the services are performed.
Added
We manufacture our proprietary H-Coils and outsource the manufacture of certain components, including the stimulator, the computer controlling the stimulator, cooling system, the helmet, and the arm of the helmet, which are produced and tested to our specifications. We assemble Deep TMS systems at our headquarters in Jerusalem, U.S. warehouses and/or installation sites.
Removed
Revenue from sale of systems is recognized at the point in time when control of the system is transferred to the customer, generally upon delivery of the system to the customer.
Added
In some cases, we rely on third-party providers to provide components used in existing products and we expect to continue to do so for future products. Our production activities also include manually assembling certain components of our devices for all required clinical and commercial quantities, and the integration of all components into a functioning Deep TMS system.
Removed
We generate lease revenue from a fixed-fee lease model in which the Deep TMS system is leased to a customer for a fixed annual fee, generally for a term of between 48 to 60 months, allowing for unlimited use during the lease period.
Added
We rely on suppliers for most of the components used in manufacturing Deep TMS, including the computer controlling the stimulator, the helmet, and the arm of the helmet. In addition, we rely on the outsourcing company utilized for the manufacture of our newer systems, including our proprietary stimulator and various other components.
Removed
Leases in which substantially all the risks and rewards incidental to ownership of the leased asset are not transferred to the lessee are classified as operating leases. Revenues from operating leases are recognized on a straight-line basis over the lease term. Usage based fees are recognized as revenue when the Company is entitled to receive such revenue.
Added
We manage our arrangements with our third-party manufacturers and suppliers to adjust delivery schedules and quantities of components to match our changing manufacturing requirements. We forecast our component needs based on historical trends, current utilization patterns, and sales forecasts of future demand. We establish our relationships with our third-party manufacturers and suppliers through supplier contracts and purchase orders.
Removed
The amount of the allowance is sensitive to changes in circumstances and forecasted economic conditions. Royalty Bearing Governmental Grants Government grants are recognized when there is reasonable assurance that the grants will be received, and the Company will comply with all attached conditions.
Added
In most cases, these supplier relationships may be terminated by either party upon short notice. The prices that we pay for sourced components vary depending on various factors, including the cost of the raw materials required for those components, our required delivery times, and shipping costs.
Removed
Government grants received from the IIA and repayable to the IIA through royalty-bearing sales are recognized upon receipt as a liability if future economic benefits are expected to be derived through estimated future cash flows from the research project, resulting in royalty bearing sales due to the IIA.
Added
In order to mitigate the risks related to a single-source of supply, we qualify alternative suppliers when possible, maximize the use of commercial, off the shelf components and materials, minimize specialized or proprietary manufacturing processes, and develop contingency plans for responding to disruptions, including maintaining adequate inventory of any critical components.
Removed
A liability for the grant is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the amount of the grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research and development expenses.
Added
For further discussion of the risks related to our supply chain, see “ Risk Factors – Our operations could be affected in the event of further geopolitical instability, war, supply chain disruptions, unfavorable market or political conditions, global pandemics or other outbreaks or other negative global trends or disruptions ”.
Removed
After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty payments are recorded as a reduction of the liability. If no economic benefits are expected from the research activity, the grants received are recognized as a reduction of the related research and development expenses.
Added
To date, the supply of finished products to our customers and clinicians has not been materially adversely affected as a result of component supply issues. We are subject to extensive governmental regulation in connection with the manufacture of our devices.
Removed
In that event, the royalty obligation is treated as a contingent liability.
Added
We must ensure that all of the processes, methods, and equipment are compliant with the current Quality System Regulations (QSR) for devices on an ongoing basis, mandated by the FDA and other regulatory authorities, and must conduct extensive audits of vendors, contract laboratories and suppliers. We comply with such regulatory requirements.
Removed
On each reporting date, the Company evaluates whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid based on the best estimate of future sales and using the original effective interest method and, if so, the appropriate amount of the liability is derecognized against a corresponding reduction in research and development expenses.
Added
Certain of our foreign marketing authorizations require compliance of said manufacturing process with the ISO 13485 standard and with the Medical Device Single Audit Program (MDSAP), with which we are compliant.
Removed
Grants received from the IIA prior to January 1, 2009, which are recognized as a liability, are accounted for as forgivable loans in accordance with IAS 20, based on the original terms of the loan.
Added
Reimbursement We estimate that over 90% of the total private insurer adult covered lives in the United States have coverage for reimbursement of MDD treatment with Deep TMS, available after one to four failed (inadequate response or intolerable) trials of antidepressant medications.
Removed
Share-based compensation Share-based compensation reflects the compensation expense of our stock option, and restricted share unit (RSU) programs granted to employees and other service providers, in which the compensation expense is measured at the grant date fair value of the award.
Added
In addition, our MDD treatment with Deep TMS is eligible for reimbursement from Medicare, and is available after one to two failed trials of psychopharmacologic agents (such as antidepressant medications) and subject to the satisfaction of other clinical criteria.
Removed
The grant date fair value of share-based compensation is recognized as an expense over the requisite service period, net of estimated forfeitures.
Added
Typically, payors (including Medicare) will provide reimbursement for up to 36 treatment sessions of Deep TMS for MDD, although the maximum number of covered sessions varies by insurer and/or location. 80 Recently, United HealthCare has updated their Medicare Advantage policy in states covered by National Government Services Medicare to allow non-physician practitioners, like nurse practitioners, to order and administer TMS Therapy to their patients with MDD in states where they have scope of practice to do so.
Removed
We recognize compensation expense for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method and classify these amounts in our statement of comprehensive loss based on the department to which the related employee/service provider reports.
Added
Similarly, Aetna nationwide commercial plans (with 16.8 million covered lives), recently allowed TMS treatment to be ordered and administered by behavioral health nurse practitioners for patients with MDD, and has removed the previously required four-month psychotherapy trial before a patient becomes eligible to receive an initial course of treatment with TMS.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

39 edited+18 added−19 removed13 unchanged
He co-founded the Guangzhou Sino-Israel Bio-industry Investment Fund (GIBF) which focuses on introducing Israeli and western life sciences companies to the Chinese market (and related investments), where he also serves as a Managing Partner & CEO. Between 2004 and 2015 Mr. Lushi served as a Partner and Managing Director of Israel Healthcare Ventures (IHCV), a life sciences venture capital fund.
Lushi co-founded the Guangzhou Sino-Israel Bio-industry Investment Fund (GIBF) which focuses on introducing Israeli and western life sciences companies to the Chinese market (and related investments), where he also serves as a Managing Partner & CEO. Between 2004 and 2015 Mr. Lushi served as a Partner and Managing Director of Israel Healthcare Ventures (IHCV), a life sciences venture capital fund.
Zacut has been working as a senior practicing physician at Hadassah Hospital, and from 1994 through 2003, he served as a managing director of several large medical centers. In addition, Dr. Zacut serves as a director of several private companies, including Brain Research and Development Services. Dr. Zacut holds an M.D. degree from the Hebrew University of Jerusalem.
Zacut has been working as a senior practicing physician at Hadassah Hospital, and from 1994 through 2003, he served as a managing director of several large medical centers. In addition, Dr. Zacut serves as a director of several private companies, including Brain Research and Development Services Ltd. Dr. Zacut holds an M.D. degree from the Hebrew University of Jerusalem.
Sarid served as VP Beauty and Dental and as Chairman of China activities at Syneron Medical Ltd. Between January 2012 and August 2013 Ms. Sarid served as President of Alma Lasers Ltd. Ms. Sarid currently serves as a director of Eva Visual Ltd. She holds a BA in Economics and Accounting from the University of Haifa. Prof.
Sarid served as VP Beauty and Dental and as Chairman of China activities at Syneron Medical Ltd. Between January 2012 and August 2013 Ms. Sarid served as President of Alma Lasers Ltd. Ms. Sarid currently serves as a director of Eva Visual Ltd. She holds a BA in Economics and Accounting from the University of Haifa. 107 Prof.
Previously, he served as CFO and Chief Operating Officer of The Jewish Agency in North America and as Vice President of Finance of Ness Technologies, a global provider of IT services. Mr. Marom is a Certified Public Accountant and holds a BA in Accounting and Finance from Haifa University, Israel. Dr.
Previously, he served as CFO and Chief Operating Officer of The Jewish Agency in North America and as Vice President of Finance of Ness Technologies, a global provider of IT services. Mr. Marom is a Certified Public Accountant and holds a BA in Accounting and Finance from Haifa University, Israel.
His research is directed at identifying and understanding altered neuroplasticity in psychiatric disorders, primarily depression, addiction and ADHD, utilizing brain stimulation, and imaging techniques to explore mechanisms and potential clinical applications. He co-developed, along with Dr. Yiftach Roth, the Deep TMS coil which serves as BrainsWay’s platform technology.
His research is directed at identifying and understanding altered neuroplasticity in psychiatric disorders, primarily depression, addiction and ADHD, utilizing brain stimulation, and imaging techniques to explore mechanisms and potential clinical applications. He co-developed, along with Dr. Yiftach Roth, the Deep TMS coil which serves as our platform technology.
David Zacut serves as Vice-Chairman of our Board of Directors since February 2023. Prior to that he served as our Chairman of the Board of Directors since our inception, is a member of our executive committee, and has been providing consulting services to Brain Research and Development Services since May 2001. Since 1983, Dr.
David Zacut has served as Vice-Chairman of our Board of Directors since February 2023. Prior to that he served as our Chairman of the Board of Directors since our inception. Dr. Zacut is a member of our executive committee, and has been providing consulting services to Brain Research and Development Services Ltd. since May 2001. Since 1983, Dr.
(TASE listed), Galam Ltd., and Greenstream Ltd., and has worked closely with management teams across the continuum of business and corporate development activities. Mr. Boehm received a Master of Business Administration from Northwestern University and Tel-Aviv University, a Bachelor of Law from Tel-Aviv University, and a Bachelor of Economics from Tel-Aviv University. 61 Dr.
(TASE listed), Hamlet Ltd. (TASE listed), Galam Ltd., and Greenstream Ltd., and has worked closely with management teams across the continuum of business and corporate development activities. Mr. Boehm received a Master of Business Administration from Northwestern University and Tel-Aviv University, a Bachelor of Law from Tel-Aviv University, and a Bachelor of Economics from Tel-Aviv University. Dr.
(3) Value of Equity Based Compensation Granted consists of the fair value of the equity-based compensation granted during the year ended December 31, 2023 in exchange for the directors' and officers' services recognized as an expense in profit or loss and is carried to the accumulated deficit under equity.
(3) Value of Equity Based Compensation Granted consists of the fair value of the equity-based compensation granted during the year ended December 31, 2024 in exchange for the directors’ and officers’ services recognized as an expense in profit or loss and is carried to the accumulated deficit under equity.
On November 14, 2023, our directors adopted the Policy for Recovery of Erroneously Awarded Compensation (the “Compensation Recovery Policy”), which provides for certain incentive-based compensation awarded to our officers to be recovered in the event that we are required to prepare an accounting restatement to correct material noncompliance with any financial reporting requirement to which we are subject.
On November 14, 2023, our directors adopted the Policy for Recovery of Erroneously Awarded Compensation, or the Compensation Recovery Policy, which provides for certain incentive-based compensation awarded to our officers to be recovered in the event that we are required to prepare an accounting restatement to correct material noncompliance with any financial reporting requirement to which we are subject.
Out of that amount, $1.7 million was paid as salary, $0.3 million was attributed to the value of the equity-based awards granted to senior management during 2023 and approximately $0.3 million was attributed to retirement plans. No additional amounts have been set aside or accrued by us to provide pension, retirement, or similar benefits.
Out of that amount, $3 million was paid as salary, $1 million was attributed to the value of the equity-based awards granted to senior management during 2024 and approximately $0.3 million was attributed to retirement plans. No additional amounts have been set aside or accrued by us to provide pension, retirement, or similar benefits.
Avner Hagai has served as our Director since November 2006 and currently serves as a member of our compensation committee and our nomination committee . He currently serves as a director at several companies, including at Prisma F.S.
Avner Hagai has served as a member of our Board of Directors since November 2006 and currently serves as a member of our compensation committee and our nomination committee. He currently serves as a director at several companies, including at Prisma F.S.
Mitrany received her BA in Economics and an MBA in Finance, both from Tel-Aviv University. Karen Sarid has served as our Director since December 2017, currently serves as chairperson of our audit committee, and is a member of our compensation committee and our executive committee. Between March 2014 and July 2017, Ms.
Mitrany received her BA in Economics and an MBA in Finance, both from Tel-Aviv University. Karen Sarid has served as a member of our Board of Directors since December 2017, currently serves as chairperson of our audit committee, and is a member of our compensation committee and our executive committee. Between March 2014 and July 2017, Ms.
Eti Mitrany has served as our Director since June 2016, and currently serves as chairperson of our compensation committee and a member of our audit committee. Ms. Mitrany is an executive with over 25 years of global experience in the life sciences industry.
Eti Mitrany has served as a member of our Board of Directors since June 2016, and currently serves as chairperson of our compensation committee and a member of our audit committee. Ms. Mitrany is an executive with over 25 years of global experience in the life sciences industry. Ms.
This description of the Compensation Recovery Policy is qualified by reference to the full text of such policy, which is filed as an exhibit hereto. 62 The table and summary below outline the actual compensation granted or paid to our five highest compensated officers during the year ended December 31, 2023.
This description of the Compensation Recovery Policy is qualified by reference to the full text of such policy, which is filed as an exhibit hereto. 108 The table and summary below outline the actual compensation granted or paid to our five highest compensated officers during the year ended December 31, 2024.
In addition, he serves as a board member of several private companies as part of his role at GIBF. From 1997 to 2001, prior to turning to the private sector, he held increasingly senior roles within the Israeli Prime Minister’s Chamber and the Israeli Supreme Court. Mr.
In addition, as part of his role at GIBF, he serves as a board member of Silexion Therapeutics Corp. (Nasdaq listed) and of several private companies. From 1997 to 2001, prior to turning to the private sector, he held increasingly senior roles within the Israeli Prime Minister’s Chamber and the Israeli Supreme Court. Mr.
Roth worked in the Advanced Technology Center of the Chaim Sheba Medical Center at Tel Hashomer as a researcher in the field of Magnetic Resonance Imaging (MRI). Dr. Roth holds B.Sc. and M.Sc. degrees in Physics and a Ph.D. in Medical Physics from Tel Aviv University. Dr.
Roth became our Chief Scientist. From 2003 through 2006, Dr. Roth worked in the Advanced Technology Center of the Chaim Sheba Medical Center at Tel Hashomer as a researcher in the field of Magnetic Resonance Imaging (MRI). Dr. Roth holds B.Sc. and M.Sc. degrees in Physics and a Ph.D. in Medical Physics from Tel Aviv University. Dr.
Avraham Zangen has served as our Director since June 2019. Prof. Zangen is the Head of the Brain Stimulation and Behavior Lab and the Chair of the PsychoBiology Brain Program at Ben-Gurion University in Israel.
Abraham Zangen has served as a member of our Board of Directors since June 2019. Prof. Zangen is the Head of the Brain Stimulation and Behavior Lab and the Chair of the PsychoBiology Brain Program at Ben-Gurion University in Israel.
(NASDAQ listed) since July 2022. Prior to his service at the Company, from August 2011 to September 2014 Mr. Levy served as Chief Financial Officer of the Latin American Division at Amdocs; and from 2008 to 2011, served as Chief Financial Officer & Vice President of Business Development of Notalvision.
Levy also serves as a director in ReWalk Robotics Ltd. (Nasdaq listed) since July 2022. Prior to joining us, from August 2011 to September 2014 Mr. Levy served as Chief Financial Officer of the Latin American Division at Amdocs; and from 2008 to 2011, served as Chief Financial Officer & Vice President of Business Development of Notalvision.
Executive officers Hadar Levy serves as our Chief Executive Officer since February 13, 2023. Prior to this, Mr. Levy served as our Senior Vice President and General Manager North America since May 2020, and before that as Chief Financial Officer from September 2014 to May 2020. Mr. Levy also serves as a director in ReWalk Robotics Ltd.
(4) Member of our nomination committee. 105 Executive Officers Hadar Levy has served as our Chief Executive Officer since February 13, 2023. Prior to this, Mr. Levy served as our Senior Vice President and General Manager North America since May 2020, and before that as Chief Financial Officer from September 2014 to May 2020. Mr.
Hanlon received a B.S. from the University of Florida in 2001 and a Ph.D. in Neurobiology from Duke University in 2005. Directors Ami Boehm serves as our Director since January 12, 2023, and as Chairman of our Board of Directors since February, 2023. Mr. Boehm has deep expertise in providing strategic advice for companies operating in multiple global industries.
Hanlon received a B.S. from the University of Florida in 2001 and a Ph.D. in Neurobiology from Duke University in 2005. 106 Directors Ami Boehm has served as a member of our Board of Directors since January 12, 2023, and as Chairman of our Board of Directors since February 2023. Mr.
David Zacut(3) 72 Vice Chairman of the Board Avner Hagai(2)(4) 68 Director Eti Mitrany(1)(2) 54 Director Karen Sarid(1)(2)(3) 73 Director Prof. Abraham Zangen 54 Director Yossi Ben Shalom(3)(4) 67 Director Avner Lushi(1)(4) 57 Director (1) Member of our audit committee, which also serves as our financial statements committee. (2) Member of our compensation committee.
David Zacut (3) 72 Vice Chairman of the Board Avner Hagai (2)(4) 68 Director Eti Mitrany (1)(2) 54 Director Karen Sarid (1)(2)(3) 73 Director Prof. Abraham Zangen 54 Director Avner Lushi (1)(4) 58 Director Jonathan Shulkin (4) 50 Director (1) Member of our audit committee. (2) Member of our compensation committee. (3) Member of our executive committee.
Roth is the brother-in-law of Professor Zangen, a director and scientific consultant for the Company . Christopher Boyer has served as our Vice President Global Marketing since June 2020.
Roth is the brother-in-law of Professor Zangen, a director and scientific consultant for the Company . Colleen Hanlon has served as our Vice President Medical Affairs since November 2022.
Compensation The aggregate compensation paid, and benefits-in-kind granted to or accrued on behalf of all of our directors and executive officers for their services, in all capacities, to us during the year ended December 31, 2023, was approximately $2.3 million.
Shulkin holds a B.B.A. in Accounting (with honors) from the University of Texas at Austin. B. Compensation The aggregate compensation paid, and benefits-in-kind granted to or accrued on behalf of all of our directors and officers for their services to us, in all capacities, during the year ended December 31, 2024, was approximately $4.9 million.
The following table sets forth the name, age and position of each of our executive officers and directors as of the date of this Annual Report. Name Age Position Senior Management: Hadar Levy 50 Chief Executive Officer Ido Marom 48 Chief Financial Officer Dr.
The following table sets forth the name, age and position of each of our executive officers and directors as of the date of this Annual Report.
From 2001 to 2005, he co-founded and served as CEO of Life Sciences Transaction Support Ltd. (LTS), a PwC subsidiary dealing with life sciences investment banking. Since 2005, Mr. Lushi has served as an independent board member at nine public companies, the two active one being Ram-On Investments and Holdings (1999) Ltd.
From 2001 to 2005, he co-founded and served as CEO of Life Sciences Transaction Support Ltd. (LTS), a PwC subsidiary dealing with life sciences investment banking. Since 2005, Mr. Lushi served as an independent board member at ten public companies, of which he remains a board member in Ginegar Plastic Product Ltd. (TASE listed).
He has served as Chairman of the Board or Director of numerous public and private companies, including Ormat Technologies, Inc. (NYSE and TASE listed), Gilat Satellite Networks, Ltd. (NASDAQ and TASE listed), TAT Industries Ltd. (NASDAQ and TASE listed), Kamada Ltd. (NASDAQ and TASE listed), Rekah Pharmaceutical Industries, Ltd. (TASE listed), Novolog Ltd. (TASE listed), Hamlet, Ltd.
(Nasdaq and TASE listed), and a director at Leumi Partners and the IL Investors Forum. Mr. Boehm also previously served as chairman or director of numerous other public and private companies, including Ormat Technologies, Inc. (NYSE and TASE listed), TAT Industries Ltd. (Nasdaq and TASE listed), Kamada Ltd. (Nasdaq and TASE listed), Rekah Pharmaceutical Industries Ltd. (TASE listed), Novolog Ltd.
The total amount is recognized as an expense over the vesting period of the RSUs and/or options. (4) “All Other Compensation” includes, among other things, bonuses, car-related expenses (including tax gross-up) and communication expenses. (5) Hadar Levy was granted 320,000 options on February 13, 2023 subject to a 4-year vesting period. Equity referenced for Mr.
The total amount is recognized as an expense over the vesting period of the RSUs and/or options. (4) Hadar Levy was granted 320,000 options on February 13, 2023 subject to a 4-year vesting period and 187,500 options on March 5, 2024 subject to a 4-year vesting period.
Yiftach Roth is one of our scientific founders and key inventors of the Deep TMS technology. Dr. Roth has led and/or participated in our key scientific and Research and Development initiatives since May 2006. In 2010, Dr. Roth became our Chief Scientist. From 2003 through 2006, Dr.
Moiseyev holds a B.Sc. in Mechanical Engineering, an M.Sc. in Computational Mechanics and a Ph.D. in Computational Mechanics, all from the Technion, Israel. Yiftach Roth is one of our scientific founders and key inventors of the Deep TMS technology. Dr. Roth has led and/or participated in our key scientific and Research and Development initiatives since May 2006. In 2010, Dr.
For more information, please see our proxy statement filed on February 13, 2023 and resulting resolution approved by the shareholders on March 20, 2023. We also have a consultancy agreement with Prof. Zangen, a director and scientific founder of the Company. For more information, please see “
We also have a consultancy agreement with Prof. Zangen, a director and scientific founder of the Company. For more information, see “
The compensation terms for our directors and officers are derived from their employment agreements and/or board/shareholder approvals, and comply with our Amended and Restated Compensation Policy for Executive Officers and Directors, which was approved by our shareholders on December 22, 2021 and amended with the consent of our shareholders on March 20, 2023 (as amended, the “Compensation Policy”).
The compensation terms for our directors and officers are derived from their employment agreements and/or board/shareholder approvals, and comply with our Compensation Policy for office holders, which was most recently approved by our shareholders on June 17, 2024, or the Compensation Policy.
For information regarding the terms of our equity incentive plans, please see the section titled “Award Plans” under Item 6.E. In addition, all of our directors and executive officers are covered under our directors’ and executive officers’ liability insurance policies and were granted letters of indemnification by us.
In addition, all of our directors and executive officers are covered under our directors’ and executive officers’ liability insurance policies and were granted letters of indemnification and exculpation by us.
Boehm’s compensation from the date of his appointment as a director on January 1, 2023 until his appointment as Chairman was the same as that applicable to our other non-executive directors) Mr. Boehm receives a monthly compensation of NIS 22,500 plus VAT for his term in office (calculated based on 30% capacity of a NIS 75,000 full capacity role).
Ami Boehm serves as an active chairman of our Board of Directors. During his term as Chairman of the Board in the year ended December 31, 2023, Mr. Boehm received a monthly compensation of NIS 22,500 plus VAT for his term in office (calculated based on 30% capacity of a NIS 75,000 full capacity role).
From 2004 until 2022, he served as a partner at FIMI Opportunity Funds, Israel’s leading private equity firm. As a partner at FIMI, Mr. Boehm has sourced and led dozens of control equity investments, and led improvement processes of FIMI’s portfolio companies and strategic activities of the portfolio companies in Israel, China, Europe and the U.S.
Boehm has sourced and led dozens of control equity investments, and led improvement processes of FIMI’s portfolio companies and strategic activities of the portfolio companies in Israel, China, Europe and the U.S. Mr. Boehm currently serves as Chairman of the board of directors of Gilat Satellite Networks Ltd.
She has served as an active board member since January 2023 at TrioxNano, a nanotechnology treatment company, and also serves as a consultant at pharmaceutical and digital health companies. From April 2021 until December 2022, she served as CFO and Head of Corporate Strategy at CytoReason, a life sciences AI company developing a computational model of the human body.
Mitrany currently serves as the CEO of the IL Investors Forum, Chairwoman at Derma Gene Ltd. and a member of Maccabi Healthcare Council. From April 2021 until December 2022, she served as CFO and Head of Corporate Strategy at CytoReason, a life sciences AI company developing a computational model of the human body.
Lushi holds an LLM in Law from the Hebrew University of Jerusalem, LLB in Law and a BA in Economics from the Haifa University. B.
Lushi holds an LLM in Law from the Hebrew University of Jerusalem, and an LLB in Law and a BA in Economics from the Haifa University. Jonathan Shulkin has served as a member of our Board of Directors since November 2024. Mr. Shulkin has over 25 years of experience in private equity investing. Mr.
Employment Agreements We have entered into written employment or service agreements with each member of our senior management. All of these agreements contain customary provisions regarding noncompetition, confidentiality of information, and assignment of inventions. However, the enforceability of the noncompetition provisions may be limited under applicable laws.
All of these agreements contain customary provisions regarding noncompetition, confidentiality of information, and assignment of inventions. However, the enforceability of the noncompetition provisions may be limited under applicable laws. 109 Director Compensation As of the date of the filing of this annual report, we pay our non-executive directors (i.e., all directors other than Mr. Boehm and Prof.
Ben-Shalom served as Chief Financial Officer of Tadiran Ltd. between 1994 and 1998. Mr. Ben Shalom holds a BA in Economics and an MA in Business Administration both from Tel Aviv University. Avner Lushi has served as our Director since January 2020 and currently serves as a member of our audit committee and our nomination committee .
Avner Lushi has served as a member of our Board of Directors since January 2020 and currently serves as a member of our audit committee and our nomination committee. Mr.
Yiftach Roth 54 Chief Scientist Christopher Boyer 46 Vice President of Global Marketing Moria Ben Soussan (Ankri) 40 Vice President of Research and Development Colleen Hanlon, PhD 44 Vice President of Medical Affairs Directors: Ami Boehm 55 Chairman of the Board Dr.
Name Age Position Executive Officers Hadar Levy 51 Chief Executive Officer Ido Marom 49 Chief Financial Officer Gilead Moiseyev, PhD 53 Chief Technology Officer Yiftach Roth, PhD 55 Chief Scientist Colleen Hanlon, PhD 45 Vice President of Medical Affairs Directors: Ami Boehm 55 Chairman of the Board Dr.
For information on exemption and indemnification letters granted to our directors and officers, please see “Item 6C. – Board Practices – Exculpation, Insurance and Indemnification of Directors and Officers.” Director Compensation As of the date of the filing of this annual report, we pay our non-executive directors (i.e., all directors other than Mr. Boehm and Prof.
For information on exemption and indemnification letters granted to our directors and officers, please see “ Item 6.C.—Board Practices—Exculpation, Insurance and Indemnification of Directors and Officers .” Employment Agreements We have entered into written employment or service agreements with each member of our senior management.
Removed
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management Recent Developments In the beginning of 2023, we underwent a transition in our leadership. Our board of directors appointed Mr. Ami Boehm, an experienced, accomplished, and well-respected leader in capital markets, investing, and advising in multiple global industries, as our new Chairman, succeeding Dr.
Added
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management Recent Developments In connection with the consummation of the private placement of the ADSs and warrants to purchase ADSs on November 5, 2024, Mr. Yossi Ben Shalom resigned from our Board of Directors and Mr. Jonathan Shulkin was appointed as a member of our Board of Directors.
Removed
David Zacut, co-founder of BrainsWay, who has held the role of Chairman since our inception, and now serves as a vice chairman on the board . In tandem with the transition to a new Chairman, on February 13, 2023, our board of directors appointed Mr.
Added
Gilead Moiseyev has served as our Chief Technology Officer since March 2024. Prior to BrainsWay, Gilead spent five years at Magenta Medical as Chief Operating Officer, developing a percutaneously implanted, expandable, coronary pump. Before Magenta, Gilead spent 16 years at Medinol, where he helped develop and bring to market an array of both coronary and peripheral systems. Mr.
Removed
Hadar Levy as our new Chief Executive Officer, and on May 23, 2023 our board of directors appointed Mr, Ido Marom, an experienced senior financial leader in global industries, including medical technology, as the Company’s new Chief Financial Officer (CFO).
Added
Boehm has deep expertise in providing strategic advice for companies operating in multiple global industries. From 2004 until 2022, he served as a partner at FIMI Opportunity Funds, Israel’s leading private equity firm. As a partner at FIMI, Mr.
Removed
(3) Member of our executive committee (4) Member of our nomination committee. Board Diversity Matrix Nasdaq’s Board Diversity Rule is designed to encourage a minimum board diversity objective for companies and provide stakeholders with consistent, comparable disclosures concerning a company’s current board composition.
Added
Shulkin is a Partner and Co-President of Valor Equity Partners, the Fund Manager for Valor Siren Ventures I L.P. (together with its parallel funds, “VSV I”) and Valor Siren Ventures II L.P. (together with its parallel funds, “VSV II”) and as a member of all Valor Equity Partners Investment Committees. Mr.
Removed
The rule requires companies listed on Nasdaq to: (1) publicly disclose board-level diversity statistics using a standardized template; and (2) have or explain why they do not have at least two diverse directors. 60 Our current board composition is reflected in the following matrix: Board Diversity Matrix (As of March 28, 2024) Country of Principal Executive Offices: Israel Foreign Private Issuer Yes Disclosure Prohibited under Home Country Law No Total Number of Directors 8 Female Male Non- binary Did Not Disclose Gender Part I: Gender Identity Directors 2 6 0 0 Part II: Demographic Background Underrepresented Individual in Home Country Jurisdiction 0 LGBTQ+ 0 Did Not Disclose Demographic Background 0 Directors who are Jewish People 8 Directors with Disabilities 0 As a Foreign Issuer subject to the added flexibility provided under Nasdaq’s Board Diversity Rule, we currently meet the diversity objectives promulgated under this rule by having two female directors, as reflected in the above matrix.
Added
Shulkin oversees Valor Equity Partners’ Scale Group, Finance, and People Teams. Currently, Mr. Shulkin is a Director of several Valor Equity Partners growth fund and VSV portfolio companies, including Gopuff, Misfits Market, Spot & Tango, and Rarefied Atmosphere. Prior to Valor, from 1998 until 2001 Mr. Shulkin was part of MG Capital’s Investment and Portfolio Team.
Removed
Prior to joining the Company, he served as Managing Director of Drake Partners LLC, a start-up private equity and management consulting firm, where he led commercial activities for many of the portfolio companies. Prior to Drake Partners, he was Vice President at St. Jude Medical (now part of Abbott), where he managed the commercial integration of NeuroTherm, Inc.
Added
During his tenure at MG Capital, he worked on acquisition teams focused on executing transactions in the electronic connector industry. Mr. Shulkin served in operational roles at MG Capital’s portfolio companies, including Chief Operating Officer of Connector Service Corporation’s Plating Division, where he managed the business through 100% growth over a 12-month period. Mr.
Removed
He was formerly the Vice President, America Sales, and Global Marketing for NeuroTherm, an international pain management company, where he transformed the sales and marketing organizations to accelerate revenue growth. This effort contributed to the subsequent sale of the company to St. Jude Medical. Earlier in his career, Mr.
Added
Shulkin also served as President of Electronic Plating Service and Chief Operating Officer for Amax Plating, Electronic Plating Service, and Associated Plating Company. Prior to joining MG Capital, from 1997 to 1998 Mr. Shulkin worked with Bain & Company as an Associate Consultant. At Bain, he worked on assignments for various Fortune 500 clients in Texas and Australia. Mr.
Removed
Boyer held marketing roles of increasing responsibility at Smith & Nephew and Stryker. Prior to his medical device career, he was a field artillery captain in the United States Army, and he received a Bronze Star Medal for his service. Mr. Boyer holds a B.S. in Mathematical Sciences from the United States Military Academy at West Point.
Added
Name and position of director or officer Base Salary or Other Payments (1) Value of Social benefit (2) Value of Equity Based Compensation Granted (3)(4) All Other Compensation (5) Total Hadar Levy, CEO $ 276,427 $ 72,674 $ 261,809 $ 193,394 $ 804,304 Ido Marom, CFO $ 178,696 $ 50,941 $ 92,378 $ 73,562 $ 395,577 Colleen Hanlon, PhD, VP of Medical $ 240,248 $ 27,240 $ 28,177 $ 60,000 $ 355,665 Michael Cohen, VP US Sales $ 191,620 $ 50,592 $ 30,971 $ 155,226 $ 428,409 Ross Mitchell, VP Marketing $ 195,371 $ 51,321 $ 19,685 $ 40,800 $ 307,177 (1) “Base Salary or Other Payments” means the aggregate yearly gross monthly salaries or other payments with respect to our senior management and members of the board of directors which was actually paid during the year ended December 31, 2024.
Removed
Moria Ben Soussan (Ankri) has served as our Vice President of Research and Development since September 2017. Prior to her service as a Vice President of Research and Development, from 2010 to 2017, Ms. Ankri served as a manager at the Biomedical Development Department of our Company and as a research and development project manager at our Company. Ms.
Added
(5) “All Other Compensation” includes, among other things, bonuses, car-related expenses (including tax gross-up) and communication expenses. Certain equity-based compensation listed in the table above was granted pursuant to an equity incentive plan. For information regarding the terms of our equity incentive plans, please see the section titled “Award Plans” under Item 6.E.
Removed
Ankri holds a B.Sc. in Biomedical Engineering from the Jerusalem College of Technology, and a B.Sc. in neurobiology studies at the Hebrew University of Jerusalem. Colleen Hanlon, PhD has served as our Vice President Medical Affairs since November 2022.
Added
As approved by our shareholders at the 2024 AGM, commencing January 1, 2024 Mr. Boehm’s monthly compensation was increased (as approved by our shareholders) to NIS 30,000 plus VAT (calculated based on 40% capacity of a NIS 75,000 full capacity role) and Mr.
Removed
Yossi Ben Shalom has served as our Director since December 2018 and is a member of our executive committee and our nomination committee . Mr. Ben Shalom is a co-founder of D.B.S.I, a private investment company specializing in investments in mature companies that are positioned globally for high growth or built for vast expansion through M&As. As such, Mr.
Added
Boehm is paid a monthly amount of NIS 5,000 as reimbursement of reasonable per diem expenses, including traveling expenses and expenses associated with attending meetings. In addition, as approved by our shareholders at the 2024 AGM, Mr.
Removed
Ben Shalom serves as the Chairman of Pointer Telocation Ltd. (Nasdaq: PNTR), Rada (Nasdaq: RADA) and Shagrir Group Car Services Ltd. (TASE: SHGR). He also serves as a director at Taldor Computer Systems (1986) Ltd.
Added
Boehm was granted: (i) 75,000 options to purchase our Ordinary Shares at an exercise price equal to NIS 11.17 per share (the closing price of our Ordinary Shares on the TASE on March 4, 2024, the last trading day before our Board of Directors approved such grant); and (ii) 37,500 restricted share units, or RSUs.
Removed
(TASE: TALD), Eldan Cargo Ltd., The 8 Note Production & Distribution Ltd., Car 2 Go Ltd., Matzman Et Merutz Milenum Ltd. and Kafrit Industries (1993) Ltd. Mr. Ben Shalom was Executive Vice President and Chief Financial Officer of Koor Industries Ltd. from 1998 through to 2000. Before that, Mr.
Added
Both the grant of options and the grant of RSUs are subject to a four-year vesting period, with the first 25% vesting on the date falling 12 months following the March 5, 2024 vesting commencement date, and the remaining 75% vesting in 12 equal quarterly portions until the end of the four year period from the vesting commencement date, provided, in each case that Mr.
Removed
Name and position of director or officer* Base Salary or Other Payments(1) Value of Social benefit(2) Value of Equity Based Compensation Granted(3)(5) All Other Compensation(4) Total Hadar Levy, CEO 335 71 172 28 606 Eric Hirt, former VP U.S.
Added
Boehm continues to be a member of our Board of Directors at the time of each such vesting date. At our 2024 AGM, our shareholders also approved the grant to each of our directors then in office (other than Mr. Boehm), including Dr. David Zacut, Mr. Avner Hagai, Ms. Eti Mitrany, Ms. Karen Sarid, Prof. Abraham Zangen, Mr.
Removed
Sales(6) 373 33 (20) 0 386 Christopher Boyer, VP Global Marketing 243 49 45 0 337 Colleen Hanlon, VP Medical Affairs 255 25 26 0 306 Moria Ben Soussan (Ankri), VP R&D 139 41 50 11 241 *Compensation for Mr. Marom, our CFO, who only joined the Company in mid-2023, is not included in this table.
Added
Yossi Ben Shalom and Mr. Avner Lushi: (i) 25,000 options to purchase our Ordinary Shares at an exercise price equal to NIS 11.17 per share (the closing price of our Ordinary Shares on the TASE on March 4, 2024, the last trading day before our Board of Directors approved such grant); and (ii) 12,500 RSUs.
Removed
(1) “Base Salary or Other Payments” means the aggregate yearly gross monthly salaries or other payments with respect to our senior management and members of the board of directors which was actually paid during the year ended December 31, 2023.
Added
Both the grant of options and the grant of RSUs are subject to a four-year vesting period, with the first 25% vesting on the date falling 12 months following the March 5, 2024 vesting commencement date, and the remaining 75% vesting in 12 equal quarterly portions until the end of the four year period from the vesting commencement date, provided, in each case that the relevant grantee continues to be a member of our Board of Directors at the time of each such vesting date.
Removed
Hirt refers to a grant of RSUs from a previous year which was forfeited in 2023 upon his departure from the Company. (6) Mr. Hirt’s employment with the Company concluded on November 6, 2023. Certain equity-based compensation listed in the table above was granted pursuant to an equity incentive plan.
Added
Following his resignation from our Board of Directors in November 2024, we entered into a consultancy agreement with Mr. Ben Shalom and the grants discussed above will continue vesting for as long as the consultancy agreement is in effect.
Removed
Ami Boehm serves as an active chairman of our board of directors. Effective as of the date that Mr. Boehm was appointed as the Chairman of the Board, namely February 13, 2023 (Mr.
Added
The grants to our directors (including our Chairman of the Board) shall otherwise be in accordance with our 2019 Amended and Restated Share Incentive Plan and in compliance with all applicable laws. For more information, please see our proxy statement in connection with the 2024 AGM, submitted to the SEC on May 9, 2024.
Removed
In addition, he was granted 300,000 options to purchase Ordinary Shares of the Company, subject to a 4 year vesting schedule and acceleration in the event of a change of control, at an exercise price equal to 125% of half of the closing price of our ADSs on the Nasdaq Global Market on March 17, 2023, subject to standard terms in our Amended and Restated 2019 Share Incentive Plan and compliance with all applicable laws.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

32 edited+218 added−13 removed12 unchanged
Sponsorship of an Obesity Study at BGU In 2021, the Company entered into an addendum to a July 2012 agreement with Ben Gurion Negev Technology and Applications Ltd. which operates a lab associated with Prof. Zangen, a director of the Company. Under the terms of the addendum, we agreed to sponsor a 40-patient obesity study involving Deep TMS.
Sponsorship of an Obesity Study at BGU In 2021, we entered into an addendum to a July 2012 agreement with Ben Gurion Negev Technology and Applications Ltd. which operates a lab associated with Prof. Zangen, a director of the Company. Under the terms of the addendum, we agreed to sponsor a 40-patient obesity study involving Deep TMS.
Control by Another Corporation, Foreign Government or Other Persons To the best of our knowledge, the Company is not directly or indirectly owned or controlled by another corporation(s), by any foreign government or by any other natural or legal person(s) severally or jointly. 74 B.
Control by Another Corporation, Foreign Government or Other Persons To the best of our knowledge, the Company is not directly or indirectly owned or controlled by another corporation(s), by any foreign government or by any other natural or legal person(s) severally or jointly. B.
Avraham Zangen In April 2009, we entered into a consulting agreement, which was last amended in May 2014, with Prof. Avraham Zangen, our scientific founder and a member of our Board, under which Prof. Zangen provides advisory services to us in the field of neurobiology. Prof. Zangen’s monthly consulting fee is NIS 19,375.
Abraham Zangen In April 2009, we entered into a consulting agreement, which was last amended in May 2014, with Prof. Abraham Zangen, our scientific founder and a member of our Board, under which Prof. Zangen provides advisory services to us in the field of neurobiology. Prof. Zangen’s monthly consulting fee is NIS 19,375.
Levy was appointed as the CEO, namely February 13, 2023: Annualized gross base salary of NIS 1,020,000 (calculated on the basis of NIS 85,000 monthly); Performance-based bonus in a gross amount not exceeding six (6) months of then current base salary based on achievement of the milestones, goals and targets to be set each year by the Board; 320,000 options to purchase Ordinary Sharers of the Company, at an exercise price based on the closing price of the Company on the last trading day prior to the date of the shareholders meeting, namely March 19, 2023, subject to standard terms in the company's Amended and Restated 2019 Share Incentive Plan and compliance with all applicable laws.
Levy was appointed as the CEO, namely February 13, 2023: Annualized gross base salary of NIS 1,020,000 (calculated on the basis of NIS 85,000 monthly); Performance-based bonus in a gross amount not exceeding six (6) months of then current base salary based on achievement of the milestones, goals and targets to be set each year by the Board; 320,000 options to purchase Ordinary Sharers of the Company, at an exercise price based on the closing price of the Company on the last trading day prior to the date of the shareholders meeting, namely March 19, 2023, subject to standard terms our 2019 Plan and compliance with all applicable laws.
The number of record holders is not representative of the number of beneficial holders of the ADSs, as the ADSs of all our shareholders who hold ADSs that are traded on NASDAQ are recorded in the name of their respective brokers.
The number of record holders is not representative of the number of beneficial holders of the ADSs, as the ADSs of certain of our shareholders who hold ADSs that are traded on Nasdaq are recorded in the name of their respective brokers.
Option Grants Each of our directors and members of senior management are participants in our Share Incentive Plan, pursuant to which they receive from time to time grants of options to purchase our Ordinary Shares. For more information, see “Item 6.
Option Grants Each of our directors and members of senior management are participants in our Share Incentive Plan, pursuant to which they receive from time to time grants of options to purchase our Ordinary Shares. For more information, see “ Item 6.
None of our shareholders have different voting rights from other shareholders. We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our Company. As of March 21, 2024, there was one shareholder of record of our Ordinary Shares.
None of our shareholders have different voting rights from other shareholders. We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our Company. As of March 31, 2025, there was one shareholder of record of our Ordinary Shares.
For purposes of the table below, we deem Ordinary Shares issuable pursuant to options that are currently exercisable or exercisable within 60 days of March 21, 2024, if any, to be outstanding and to be beneficially owned by the person holding the options for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.
For purposes of the table below, we deem Ordinary Shares issuable pursuant to options or warrants that are currently exercisable or exercisable within 60 days of March 31, 2025, if any, to be outstanding and to be beneficially owned by the person holding them for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.
Significant Changes Except as otherwise disclosed in this Annual Report, no significant change has occurred since December 31, 2023.
Significant Changes Except as otherwise disclosed in this Annual Report, no significant change has occurred since December 31, 2024.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS The following table sets forth information with respect to the beneficial ownership of our Ordinary Shares as of March 18, 2024 by: ● each person or entity known by us to own beneficially 5% or more of our outstanding Ordinary Shares; ● our directors and members of senior management, or our Named Directors and Officers; and ● all of our directors and members of senior management as a group.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our Ordinary Shares as of March 31, 2025 by: ● each person or entity known by us to own beneficially 5% or more of our outstanding Ordinary Shares; ● our directors and members of senior management, or our Named Directors and Officers; and ● all of our Named Directors and Officers as a group.
Levy undertook not to compete with the products and services offered by the Company and not to do any interfering activities during the term of his employment and for 12 months of the date of termination of his employment for any reason.
Levy undertook not to compete with the products and services offered by the Company and not to do any interfering activities during the term of his employment and for 12 months of the date of termination of his employment for any reason. At our 2024 AGM, our shareholders approved a grant to Mr.
The percentage of Ordinary Shares beneficially owned is based on 33,273,984 Ordinary Shares outstanding as of March 21, 2024. Except where otherwise indicated, we believe, based on information furnished to us by such owners, that the beneficial owners of the ordinary shares listed below have sole investment and voting power with respect to such shares.
The percentage of Ordinary Shares beneficially owned set forth below is based on 37,738,456 Ordinary Shares outstanding as of March 31, 2025. 130 Except where otherwise indicated, we believe, based on information furnished to us by such owners, that the beneficial owners of the Ordinary Shares listed below have sole investment and voting power with respect to such shares.
Directors, Senior Management and Employees—Share Ownership—Award Plans.” Since January 1, 2021, we granted options to purchase 1,123,000 Ordinary Shares to employees and directors, with a weighted average exercise price, following the completion of the Exchange Offer, of approximately $1.48 per share, or approximately NIS 5.02 per share (based on the exchange rate reported by the Bank of Israel on December 31, 2023), and 269,638 restricted share units (RSUs).
Directors, Senior Management and Employees—Share Ownership—Award Plans .” Since January 1, 2022, we granted options to purchase 1,768,000 Ordinary Shares to employees and directors, with a weighted average exercise price of approximately $1.7 per share, or approximately NIS 5.97 per share (based on the exchange rate reported by the Bank of Israel on December 31, 2024), and 818,400 restricted share units (RSUs).
Export Sales For geographical breakdown of the Company’s sales, see Note 17 to the financial statements. Dividend Policy We have never declared or paid cash dividends to our shareholders. We do not have current plans to pay cash dividends in the near term. We currently intend to reinvest any future earnings, if any, in developing and expanding our business.
Dividend Policy We have never declared or paid cash dividends to our shareholders. We do not have current plans to pay cash dividends in the near term. We currently intend to reinvest any future earnings, if any, in developing and expanding our business.
Changes in Percentage Ownership by Major Shareholders Since April 19, 2021, which was the date we filed our 2020 Annual Report, we are not aware of significant changes in the reported percentage ownership held by any of our 5% or greater shareholders other than The Phoenix Provident Funds which increased from 9.7% to 11.33%, Dr.
Changes in Percentage Ownership by Major Shareholders Since April 12, 2022, which was the date we filed our Annual Report for the fiscal year ended December 31, 2021, we are not aware of significant changes in the reported percentage ownership held by any of our 5% or greater shareholders other than: (i) The Phoenix Provident Funds which decreased from 13.04% to below 5%, (ii) Dr.
Directors and Officers Insurance Policy and Indemnification Agreements Our articles of association permit us to exculpate, indemnify, and insure each of our directors and officers to the fullest extent permitted by the Israeli Companies Law. We have obtained directors and officers insurance for each of our senior management and directors.
Directors and Officers Insurance Policy and Indemnification Agreements Our articles of association permit us to exculpate, indemnify, and insure each of our directors and officers to the fullest extent permitted by the Israeli Companies Law. For information, please see “ Item 6.C.—Board Practices—Exculpation, Insurance and Indemnification of Directors and Officers .” C. Interests of Experts and Counsel Not applicable.
Related Party Transactions Employment Agreements We have entered into written employment agreements with each member of our senior management. These agreements provide for notice periods of varying duration for termination of the agreement by us or by the relevant executive officer, during which time the executive officer will continue to receive base salary and benefits.
These agreements provide for notice periods of varying duration for termination of the agreement by us or by the relevant executive officer, during which time the executive officer will continue to receive base salary and benefits. These agreements also contain customary provisions regarding noncompetition, confidentiality of information, and assignment of inventions.
Unless otherwise noted below, the address for each beneficial owner is c/o BrainsWay Ltd., 19 Hartum Street, Bynet Building 3rd Floor, Har HaHotzvim, Jerusalem, 9777518, Israel. 73 Shares Beneficially Number Percentage 5% or Greater Shareholders The Phoenix Provident Funds (1) 3,768,718 11.33 % Dr.
Unless otherwise noted below, the address for each beneficial owner is c/o BrainsWay Ltd., 16 Hartum Street, RAD Tower, 14th Floor, Har HaHotzvim, Jerusalem, 9777516, Israel. Shares Beneficially Owned Number Percentage 5% or Greater Shareholders Valor BrainsWay Holdings, LLC (1) 7,207,490 17.69 % Dr.
The maximum aggregate amount of indemnification that we may pay to our directors and senior management based on such indemnification undertaking is the greater of (i) 25% of our shareholders’ equity pursuant to our most recent audited financial statements at the time the indemnification is actually paid, and (2) $20 million.
The maximum aggregate amount of indemnification that we may pay to our office holders based on such indemnification agreement with respect to any monetary liability imposed in favor of a third party is the greater of (1) 25% of our shareholders’ equity less the minority rights pursuant to our audited or reviewed consolidated financial statements at the time the indemnification is actually paid, and (2) $20 million.
These agreements also contain customary provisions regarding noncompetition, confidentiality of information, and assignment of inventions. However, the enforceability of the noncompetition provisions may be limited under applicable law.
However, the enforceability of the noncompetition provisions may be limited under applicable law.
Employment Agreement with Ido Marom our Chief Financial Officer In September 2023 we entered into an employment agreement with Ido Marom reflecting his compensation and other terms as our new CFO. The following is a description of Mr.
Levy continues to be employed by us at the time of each such scheduled vesting date. The grants shall otherwise be in accordance with our 2019 Plan. Employment Agreement with Ido Marom our Chief Financial Officer In September 2023 we entered into an employment agreement with Ido Marom reflecting his compensation and other terms as our new CFO.
Marom undertook not to compete with the products and services offered by the Company and not to do any interfering activities during the term of his employment and for 12 months of the date of termination of his employment for any reason.
Marom undertook not to compete with the products and services offered by the Company and not to do any interfering activities during the term of his employment and for 12 months of the date of termination of his employment for any reason. 134 Engagement with executive directors We have engaged with each of our executive directors for compensation paid to them with respect to the services provided to the Company, for more information please see “ Item 6.B.—Compensation—Director Compensation .” Consulting Agreement with Prof.
As of March 22, 2024, there were 83 U.S. persons that were holders of record of ADSs representing our Ordinary Shares, representing approximately 52% of our outstanding Ordinary Shares.
As of March 31, 2025, there were 13 persons that were holders of record in the United States of ADSs representing our Ordinary Shares, representing approximately 40.6% of our outstanding Ordinary Shares.
Such indemnification amounts are in addition to any insurance amounts. C. Interests of Experts and Counsel Not applicable. 75 ITEM 8. FINANCIAL INFORMATION A. Consolidated Statements and Other Financial Information The financial statements required by this item are found at the end of this Annual Report, beginning on page F- 1.
ITEM 8. FINANCIAL INFORMATION A. Consolidated Statements and Other Financial Information The financial statements required by this item are found at the end of this Annual Report, beginning on page F-1. 135 Legal Proceedings From time to time, we may become a party to legal proceedings and claims in the ordinary course of business.
This consists of shares held directly by the named beneficial owner as well as shares held by family members or affiliates of the named beneficial owner. (3) The shares are held by Masters Capital Management, LLC and Michael Masters has beneficial ownership by virtue of his role as a control person of Masters Capital Management, LLC.
(3) The shares are held by Masters Capital Management, LLC and Michael Masters has beneficial ownership by virtue of his role as a control person of Masters Capital Management, LLC. The address of Masters Capital Management, LLC is 3060 Peachtree Road, Suite 1425, Atlanta, Georgia 30305, United States of America.
Legal Proceedings From time to time, we may become a party to legal proceedings and claims in the ordinary course of business. We are not currently a party to any significant active legal proceedings, subject to any disclosure set forth under “Item 4. Information on the Company – Business Overview – Legal Proceedings” is incorporated herein by reference.
We are not currently a party to any significant active legal proceedings, subject to any disclosure set forth under “ Item 4. Information on the Company—Business Overview—Legal Proceedings ” which is incorporated herein by reference. Export Sales For geographical breakdown of the Company’s sales, see Note 17 to the financial statements included at the end of this Annual Report.
The exercise price of the options is $4.68, with 220,000 expiring on December 8, 2025, 128,000 expiring on November 12, 2026, 50,000 expiring on October 1, 2027, and 100,000 expiring on February 9, 2033. (6) Consists of 14,000 Ordinary Shares and options to purchase 56,250 Ordinary Shares currently exercisable or exercisable within 60 days.
(10) Consists 61,630 Ordinary Shares and options to purchase 609,250 Ordinary Shares as follows: (i) options to purchase 398,000 Ordinary Shares with an exercise price per share of $4.68 expiring on December 8, 2025 (220,000 options), November 12, 2026 (128,000 options) and October 1, 2027 (50,000 options), (ii) options to purchase 180,000 Ordinary Shares with an exercise price per share of $1.3 expiring on February 9, 2033, and (iii) options to purchase 31,250 Ordinary Shares with an exercise price per share of NIS 11.17 expiring on March 5, 2034.
Each of the above listed securities entitles the holder to one vote at our Company’s shareholder meetings.
The voting rights of our major shareholders do not differ from the voting rights of holders of our Ordinary Shares who are not major shareholders. Each of our Ordinary Shares entitles the holder to one vote at our Company’s shareholder meetings.
Additionally, during this three-year period, Cowen Financial Products, LLC, Wasatch Advisors Inc. and AIGH Capital Management, LLC each became 5% or greater shareholders but have since decreased their respective holdings to below 5% as of the date of this report.
Avner Hagai which decreased from 5.3% to below 5%, (iv) Cowen Financial Products, LLC which decreased from 5.03% to below 5%, (v) RTW Funds which decreased from 9.4% to below 5%, (vi) Wasatch Advisors Inc. and AIGH Capital Management, LLC each became 5% or greater shareholders but have since decreased their respective holdings to below 5% as of the date of this report and (vii) as a result of the private placement to Valor in November 2024, Valor’s beneficial ownership increased to 17.73% (with each of the individuals holding shared voting and dispositive powers over its holdings beneficially owning additional shares as set forth above).
David Zacut which increased from 5.4% to 6.48%, and Mr. Avner Hagai which increased from 5.3% to 6.23%, and RTW Funds which decreased from 9.4% to below 5%.
David Zacut which increased from 5.4% to 5.89%, (iii) Mr.
The exercise price of the options is NIS 15.26. The options expire on January 13, 2028. (10) Consists of options to purchase 27,500 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS 15.26. The options expire on January 13, 2028.
(6) Consists of shares held directly by the named beneficial owner as well as shares held by family members or affiliates of the named beneficial owner and options to purchase 27,500 and 6,250 Ordinary Shares with an exercise price per share of NIS 15.26 and NIS 11.17, respectively, expiring on January 13, 2028 and March 5, 2034, respectively.
(11) Consists of options to purchase 93,750 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS 4.56. The options expire on February 9,2033. (12) Consists of options to purchase 37,500 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS 4.28.
(4) Consists of shares held directly by the named beneficial owner as well as shares held by family members or affiliates of the named beneficial owner and options to purchase 168,750 and 18,750 Ordinary Shares with an exercise price per share of NIS 4.56 and NIS 11.17, respectively, expiring on February 9, 2033 and March 5, 2034, respectively.
Removed
David Zacut (2) 2,157,668 6.48 % Avner Hagai (2) 2,072,517 6.23 % Masters Capital Management, LLC (3) 1,800,000 5.41 % Directors and Named Executive Officers Dr. Yiftach Roth 1,090,890 3.28 % Prof.
Added
Item 7.B. Related Party Transactions. ” 110 The table and summary below outline the actual compensation granted or paid to our directors during the year ended December 31, 2024. Name of director Annual Basis Compensation Annual Per meeting compensation Value of Equity Based Compensation Granted (1) All Other Compensation (2) Total Ami Boehm $113,544 - $162,166 - $275,710 Dr.
Removed
Avraham Zangen (4) 937,143 2.82 % Hadar Levy (5) 538,620 1.62 % Moria Ben Soussan (Ankri) (15) 74,438 * Christopher Boyer (6) 70,250 * Karen Sarid (7) 27,500 * Yossi Ben Shalom (8) 322,500 * Avner Lushi (9) 27,500 * Eti Mitrany (10) 27,500 * Ami Boehm (11) 93,750 * Ido Marom (12) 37,500 * Eric Hirt (13) 12,500 * Colleen Hanlon (14) 12,000 * All directors and members of senior management as a group 7,502,276 22.55 % * Less than 1.0% (1) The shares are beneficially owned by various direct or indirect, majority or wholly-owned subsidiaries of the Phoenix Holding Ltd.
Added
David Zacut $35,955 $4,291 $38,052 - $78,298 Prof.
Removed
(the “Phoenix Provident Funds”). The Phoenix Provident Funds manage their own funds and/or the funds of others, including for holders of exchange-traded notes or various insurance policies, members of pension or provident funds, unit holders of mutual funds, and portfolio management clients.
Added
Abraham Zangen $56,727 - $38,052 $13,194 $107,973 Karan Sarid $35,955 $19,464 $38,052 - $93,471 Eti Mitrany $35,955 $12,106 $38,052 $448 $86,561 Avner Lushi $35,955 $7,643 $38,052 $674 $82,324 Yossi Ben Shalom (3) $26,967 $2,682 $38,052 - $67,701 Avner Hagai $35,955 $6,034 $38,052 - $80,041 Jonathan Shulkin (3) $8,989 $805 - - $9,794 (1) Mainly attributed to expenses for the granting of options.
Removed
Each of the Phoenix Provident Funds operates under independent management and makes its own independent voting and investment decisions. The Phoenix Holding Ltd. Is a controlled subsidiary of Delek Group Ltd.
Added
(2) Mainly attributed to car expenses and reimbursements of travel expenses. (3) Mr. Jonathan Shulkin was appointed as a member of our Board of Directors on November 5, 2024, replacing Mr. Ben Shalom who resigned effective as of such date. Therefore, the table does not reflect the full-year compensation for these directors.
Removed
The majority of Delek Group Ltd.’s outstanding share capital and voting rights are owned, directly and indirectly, by Itshak Sharon (Tshuva) through private companies wholly-owned by him, and the remainder is held by the public. The address of the Phoenix Provident Funds is HaShalom Road 53 Giv’atayim, 5345433, Israel. (2) A director of the Company.
Added
Compensation Policy In general, under the Israeli Companies Law, a public company must have a compensation policy for its “office holders” approved by the board of directors after receiving and considering the recommendations of the compensation committee. In addition, the compensation policy requires the approval of the general meeting of the shareholders.
Removed
The address of Masters Capital Management, LLC is 3060 Peachtree Road, Suite 1425, Atlanta, Georgia 30305, United States of America. (4) The address of Prof. Avraham Zangen is Mish’ol HaHadas 23, Jerusalem, Israel. (5) Consists of 40,620 Ordinary Shares and options to purchase 498,000 Ordinary Shares currently exercisable or exercisable within 60 days.
Added
In public companies such as our Company, shareholder approval requires one of the following: (i) the majority of shareholder votes counted at a general meeting, which must include the majority of all of the votes of those shareholders who are non-controlling shareholders and do not have a personal interest in the approval of the compensation policy, who vote at the meeting (excluding abstentions) or (ii) the total number of votes against the proposal among the shareholders mentioned in paragraph (i) does exceed two percent (2%) of the voting rights in the company.
Removed
The exercise price of the options is $4.68. The options expire on June 1, 2028. (7) Consists of options to purchase 27,500 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS 15.26. The options expire on December 3, 2027.
Added
Under special circumstances, the board of directors may approve the compensation policy despite the objection of the shareholders on the condition that the compensation committee and then the board of directors decide, on the basis of detailed arguments and after discussing again the compensation policy, that approval of the compensation policy, despite the objection of the meeting of shareholders, is for the benefit of the company.
Removed
(8) Consists of 295,000 Ordinary Shares and options to purchase 27,500 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS 15.26. The options expire on November 12, 2026. (9) Consists of options to purchase 27,500 Ordinary Shares currently exercisable or exercisable within 60 days.
Added
An “office holder” is defined under the Israeli Companies Law as a general manager, chief business manager, vice general manager, any other person assuming the responsibilities of any of the foregoing positions without regard to such person’s title, and a director, or manager directly subordinate to the general manager.
Removed
The options expire on August 8, 2033. (13) Consists of 12,500 Ordinary Shares resulting from vested RSUs. Eric Hirt’s employment with the company concluded on November 6, 2023. (14) Consists of 12,000 RSUs vested or to be vested within 60 days.
Added
Each person identified as a director or member of our senior management in the first table in this Item is an office holder The compensation policy must be based on certain considerations, must include certain provisions, and needs to reference certain matters as set forth in the Israeli Companies Law.
Removed
(15) Consists of 14,438 RSUs which either vested (and thus converted to Ordinary Shares) or RSUs which will be vested within 60 days, as well as options to purchase 60,000 Ordinary Shares currently exercisable or exercisable within 60 days.
Added
The compensation policy must serve as the basis for decisions concerning the financial terms of employment or engagement of office holders, including exculpation, insurance, indemnification or any monetary payment or obligation of payment in respect of employment or engagement.
Removed
The exercise price of the options is $4.68, with 50,000 expiring on December 8, 2025, and 10,000 expiring on November 12, 2026. The voting rights of our major shareholders do not differ from the voting rights of holders of our Ordinary Shares who are not major shareholders.
Added
The compensation policy must relate to certain factors, including advancement of the company’s objectives, business plan, long-term strategy, and creation of appropriate incentives for office holders. It must also consider, among other things, the company’s risk management, size, and the nature of its operations.
Removed
Engagement with executive directors We have engaged with each of our executive directors for compensation paid to them with respect to the services provided to the Company, for more information please see “Item 6B. – Compensation –Director Compensation.” Consulting Agreement with Prof.
Added
The compensation policy must furthermore consider the following additional factors: ● the education, skills, experience, expertise, and accomplishments of the relevant office holder; ● the office holder’s position, responsibilities, and prior compensation agreements with him or her; ● the ratio between the cost of the terms of employment of an office holder and the cost of the employment of other employees of the company, including employees employed through contractors who provide services to the company, in particular the ratio between such cost, the average, and median salary of the employees of the company, as well as the impact of such disparities on the work relationships in the company; ● if the terms of employment include variable components—the possibility of reducing variable components at the discretion of the board of directors and the possibility of setting a limit on the value of variable equity-based components not settled in cash; and ● if the terms of employment include severance compensation—the term of employment or office of the office holder, the terms of his or her compensation during such period, the company’s performance during such period, his or her individual contribution to the achievement of the company goals and the maximization of its profits and the circumstances under which he or she is leaving the company. 111 The compensation policy must also include, among others: ● with regards to variable components in the terms of office and employment: ● with the exception of office holders who report directly to the chief executive officer, determining the variable components on long-term performance basis and on measurable criteria; however, the company may determine that an immaterial part of the variable components of the compensation package of an office holder shall be awarded based on non-measurable criteria, if such amount is not higher than three monthly salaries per annum, while taking into account such office holder contribution to the company; ● the ratio between variable and fixed components, as well as the limit of the values of variable components at the time of their payment.
Removed
We have provided an undertaking to our directors and senior management to exculpate to the fullest extent permitted by law and to indemnify them for certain liabilities, subject to limited exceptions, to the extent that these liabilities are not covered by insurance.
Added
However, with respect to variable equity-based components that are not settled in cash, the limit of their value at the time of grant. ● a condition under which the office holder will return to the company, according to conditions to be set forth in the compensation policy, any amounts paid as part of his or her terms of employment, if such amounts were paid based on information later to be discovered to be wrong, and such information was restated in the company’s financial statements; ● the minimum holding or vesting period of variable equity-based components to be set in the terms of office or employment, as applicable, while taking into consideration long-term incentives; and ● a limit to retirement grants.
Added
Our compensation policy is designed to promote retention and motivation of directors and senior management, incentivize superior individual excellence, align the interests of our directors and senior management with our long-term performance and provide a risk management tool.
Added
To that end, a portion of an executive officer compensation package is targeted to reflect our short and long-term goals, as well as the executive officer’s individual performance.
Added
On the other hand, our compensation policy includes measures designed to reduce the executive officer’s incentives to take excessive risks that may harm us in the long-term, such as limitations on the value of cash bonuses and equity-based compensation to a maximum number of monthly salaries, limitations on the ratio between the variable and the total compensation of an executive officer and minimum vesting periods for equity-based compensation.
Added
Our compensation policy also addresses our executive officer’s individual characteristics (such as his or her respective position, education, scope of responsibilities and contribution to the attainment of our goals) as the basis for compensation variation among our senior management, and considers the internal ratios between compensation of our senior management and directors and other employees.
Added
Pursuant to our compensation policy, the compensation that may be granted to an executive officer may include: base salary, exemption indemnification and insurance subject to certain limitations set forth therein, annual bonuses and other cash bonuses (such as a signing bonus and special bonuses with respect to any special achievements, such as outstanding personal achievement, outstanding personal effort or outstanding company performance), equity-based compensation, social benefits, retirement, and termination of service arrangements.
Added
All cash bonuses to executive officers (“Annual Target Bonus”, “Overachievement Bonus” and “Special Bonus”) are limited to a maximum amount linked to the executive officer’s base salary.
Added
In addition, the total equity-based compensation components may not exceed 200% of each executive officer’s base salary with respect to any given calendar year. 112 An annual cash bonus may be awarded to senior management upon the attainment of pre-set periodic objectives and individual targets.
Added
The annual cash bonus that may be granted to our senior management will be based on performance objectives and a discretionary evaluation of the executive officer’s overall performance by our compensation committee and board of directors and subject to minimum thresholds.
Added
Up to 25% of the annual cash bonus that may be granted to senior management may be based on a discretionary evaluation. Furthermore, our chief executive officer will be entitled to recommend performance objectives, and such performance objectives will be approved by our compensation committee (and, if required by law, by our board of directors).
Added
The equity-based compensation under our compensation policy for our officers and directors is designed in a manner consistent with the underlying objectives in determining the base salary and the annual cash bonus, with its main objectives being to enhance the alignment between the officers’ and directors’ interests with our long-term interests and those of our shareholders, and to strengthen the retention and the motivation of senior management in the long term.
Added
Our compensation policy provides for officers and directors compensation in the form of share options or other equity-based awards, such as restricted shares and restricted share units (RSUs), in accordance with our Share Incentive Plan then in place.
Added
All equity-based incentives granted to officers and directors shall be subject to vesting periods in order to promote long-term retention of the awarded officer or director.
Added
The equity-based compensation shall be granted from time to time and be individually determined and awarded according to the performance, educational background, prior business experience, qualifications, role, and the personal responsibilities of the officer or director.
Added
Our compensation policy limits the number of outstanding securities exercisable or convertible into shares to 10% of our issued and outstanding share capital on a fully diluted basis.
Added
In addition, our compensation policy contains compensation recovery provisions, which allows us under certain conditions to recover bonuses paid in excess, and includes provisions enabling our chief executive officer to approve an immaterial change in the terms of employment of an executive officer (provided that the changes of the terms of employment are in accordance with our compensation policy).
Added
Our compensation policy also provides for compensation to the members of our Board of Directors (except for directors that are employed by us, or provide services, directly or through companies in their control, to us in another role) either (i) for external directors, if any, in accordance with the amounts provided in the Companies Regulations (Rules Regarding the Compensation and Expenses of an External Director), 2000, as amended by the Companies Regulations (Relief for Public Companies Traded in Stock Exchange Outside of Israel), 2000, as such regulations may be amended from time to time, or (ii) for all other directors, in accordance with the amounts determined in our compensation policy.
Added
Our amended and restated compensation policy was last approved by our shareholders at the 2024 AGM and is valid for a period of three years according to the Israeli Companies Law. C.
Added
Board Practices Appointment of Directors and Terms of Officers Our Board of Directors consists of eight (8) directors, all of whom qualify as “independent” under applicable U.S. securities laws and Nasdaq listing rules.
Added
The term of office of each director is until the next annual general meeting of our shareholders. 113 Number and Appointment of Directors Our articles of association provide that the number of directors on our Board of Directors will be not less than four (4) but no more than eight (8) directors, including the Valor Designee(s) (as explained below) and not including any external directors to the extent required to be appointed by the Israeli Companies Law.
Added
The number of directors also does not include up to two (2) additional directors who may be appointed by our Board of Directors whose term of office would expire as of the first annual meeting of shareholders after their appointment, provided that they may be reappointed by our Board of Directors for one additional term of office and provided that they may be reappointed by the annual general meeting.
Added
Each appointed director, other than external directors, if any, shall serve as a member of the Board of Directors until the next annual general meeting. The term of a director shall terminate at the next annual general meeting, unless he or she is reelected at the annual general meeting.
Added
Pursuant to our articles of association, the vote required to appoint a director is a simple majority vote of holders of our voting shares participating and voting at the relevant meeting.

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